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Medtronic Minimed Paradigm Insulin Pump

Safety Information Article

Safety Information Article

Safety Information Article Information on this page is limited by the terms of our Disclaimer. Please Read! Insulin Pumps An insulin pump allows the replacement of slow-acting insulin for basal needs with a continuous infusion of rapid-acting insulin. By using an insulin pump, the patient can typically match the dosage of insulin to lifestyle and activities, rather than adjusting those to the body’s response to insulin injections. The advantages of using an insulin pump include the fact that it replaces the need for periodic injections by delivering rapid-acting insulin continuously throughout the day via a catheter, which greatly simplifies the management of diabetes. There are two basic types of insulin pumps, one is used as an external device and the other is implanted. Both types currently pose hazards to patients referred to MRI procedures. For an external insulin pump, in general, the device typically needs to be removed and kept out of the MRI environment to ensure that there is no adverse impact on the functionality of the external pump. The information below provides examples of MRI information for several, commonly used insulin pumps. Insulin Pumps, Animas Corporation This MRI information pertains to the following insulin pumps from the Animas Corporation: Animas 2020 Insulin Pump IR Animas 1200 IR 1000 Insulin Pump IR 1100 Insulin Pump IR 1200 Insulin Pump OneTouch Ping Insulin Pump Each insulin pump indicated above should not be exposed to very strong electromagnetic fields, such as MRIs, RF welders, or magnets used to pick up automobiles. Very strong magnetic fields, such as that associated with MRI, can “magnetize” the portion of the insulin pump’s motor that regulates insulin delivery and, thus, damage the device. For the patient: If you plan to u Continue reading >>

Minimed Paradigm Veo Insulin Pumps

Minimed Paradigm Veo Insulin Pumps

We currently provide the MiniMed640G insulin pump as standard. However, some patients may still be offered the MiniMedParadigm Veoinsulin pump by some Hospitals. This is the previous model of insulin pump developed by Medtronic and offers the following features: Pre-programmed calculator (Bolus Wizard) Insulin given for Carbohydrates excluded from Al (active insulin) Range of angled and tubing length infusion sets available Accessories available for children and adults Integrated Blood Glucose Meter (Wireless) The Paradigm Veodoes nothave the following capabilities of the MiniMed640G system: SmartGuard(predictive suspend before low) capability 'Favourite' temporary basal rates and boluses cannot be saved Remote bolus from the Blood Glucose Meter Transmitter is the MiniLink Transmitter (and not the Guardian 2 Link Transmitter) A seperate CareLinkUSB dongle is required to download pump data into the CareLinksoftware Talk with your diabetes healthcare team to dIscuss which insulin pump meets your individual needs. The MiniMed 640G insulin pump with SmartGuard Information on MiniMed 640G - the latest insulin pump from Medtronic CONTACT US ONLINE or call our 24/7 helpline. Youll never need to reschedule or wait in for deliveries again. The content and all information provided on this website is for your informational use only and is not intended to be a substitute for professional medical advice, diagnosis or treatment in any manner. The patient stories provided are experiences specific to a particular patient. Responses to a treatment may vary from patient to patient. Always talk with your physician about diagnosis and treatment information and ensure that you understand and carefully follow that information. 2016 Medtronic International Trading Sarl. All Rights Reserved. Continue reading >>

Medtronic Facing New Wrongful Death Lawsuit Over Failed Insulin Pump In Wake Of 2009 Recall

Medtronic Facing New Wrongful Death Lawsuit Over Failed Insulin Pump In Wake Of 2009 Recall

The executor of the will of a New Jersey man who died of a night-time diabetes attack is suing Medtronic ($MDT) for the alleged failure of its MiniMed insulin pump and infusion set. Joann Hassan said the company was relying on underqualified high school graduates to test the pump, leading to the device's eventual failure on Charles Slack Jr. Slack's estate says the April 2013 death occurred because he did not receive the correct dosage of insulin. "The pump, set and reservoir failed to take the necessary, expected and warranted steps to alert [Slack] of the failure," according to Courthouse News Service. The specific devices used by Slack were the MiniMed Paradigm Real-Time Revel 523 System and MiniMed Paradigm Quick-Set Infusion Sets, the estate said. Medtronic says the Revel provides continuous glucose monitoring and notification of oncoming high and low blood sugar levels, while the infusion sets consist of thin plastic tubes used to deliver insulin from the pump to the patient, the FDA says. The estate says that the diabetic attack left him "lying in his urine drenched bed, in a state of unconsciousness and unresponsiveness, yet alive." He died after spending the next several weeks hospitalized and in a coma, Courthouse News Service says. Hassan's suit seeks punitive damages for a variety of claims including breach of warranty, negligence and wrongful death. Medtronic's MiniMed infusion sets were hit by a Class I recall notice in June 2009. "These infusion sets may not allow the insulin pump to vent air pressure properly. This could potentially result in the device delivering too much or too little insulin and may cause serious injury or death," the FDA said. It followed that up with a warning letter, citing concerns about Medtronic's insulin pump manufacturing oper Continue reading >>

Medtronic Mini-med Paradigm Insulin Pump

Medtronic Mini-med Paradigm Insulin Pump

Risk of too much or too little insulin causing low or high blood sugar, loss of consciousness, death. People with diabetes use insulin to regulate their blood sugar levels. Insulin can be given by injection, but many have found an easier, more constant delivery of insulin (and no need to continue to draw blood to test levels) by using an insulin pump that attaches to their clothing at waist level. Although this is a popular option, there are risks. Defects in the tubing of the Medtronic insulin pump (infusion sets) could cause over or under delivery of insulin. The dangerous result could be hypo- or hyper- glycemia (low or high blood sugar), loss of consciousness, and possibly death. If you or someone you know has experienced these injuries or side effects, call 800-883-2299 or fill out the inquiry form on this page. If insulin or other fluids come in contact with the inside of the tubing connector it can temporarily block the vents that allow the pump to properly prime. The FDA recommends thatif you notice anything unusual during the infusion set prime process such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly. See below for the model numbers affected. The July 2013 FDA Class 1 recall states if patientsnotice anything unusual during the infusion set prime process such as the insulin continuing to drip from the tip of the infusion set cannula when priming has been completed, this may indicate that the connector vents are not working properly. If this occurs, do not insert the infusion set.Medtronic, the manufacturer of the MiniMed Paradigm Insulin Infusion Pump issued an urgent safety notification, also in July 2013.There were reports of inj Continue reading >>

Medtronic Insulin Pumps & Infusion Sets

Medtronic Insulin Pumps & Infusion Sets

The Medtronic MiniMed Paradigm Insulin Pump is designed to deliver insulin to diabetes patients, making daily injections unnecessary. Serious injury and death, from potentially defective or malfunctioning parts of the device, are being reported to the FDA. MiniMed Paradigm Insulin Pumps are designed to deliver insulin continuously, taking the place of daily, manual injections of insulin MiniMed insulin pumps are about the size of a cell phone and can be worn on a belt or placed in a pocket. The pump connects to the patient’s body with an infusion set. The set consists of a needle going into the abdomen, secured by an adhesive pad and connecting to the pump with a thin plastic tube. The infusion set tubing is designed to be replaced every several days. However, increasing incident reports of blocked sets has prompted the FDA to issue a Class 1 recall, the most serious, advising patients and health care professionals of the potential for under or over delivery of insulin. Medtronic alerted patients and healthcare officials by sending an “Urgent Medical Device Safety Notification” letter and If you or someone you know has a Medtronic MiniMed Insulin Pump and is experiencing problems or who has died, contact the defective medical device attorneys at the Harman Law Firm. Call (888) 554-2762 or contact us online. There may be a time limit to file a claim, so call now. Warning signs The following symptoms can occur with the incorrect dose of insulin. Too much or too little insulin may cause fainting, seizure, or coma. Here are the warning signs for both: Rapid heartbeat Shaking, trembling Sweating Double vision/blurry vision Headache, confusion Mood shifts, ranging from angry to nervous Fatigue, interrupted sleep Pale or tingling skin Seek medical attention immediately i Continue reading >>

Medtronic’s Newest Insulin Pump: Minimed Revel

Medtronic’s Newest Insulin Pump: Minimed Revel

I do not yet have the iPhone 4. I do, however, have the diabetic’s version of the Hot New Gadget– the Minimed Revel, Medtronic’s latest insulin pump. I am very happy to be able to try out Revel temporarily, on loan from Minimed through the Paradigm Pathway Program, so that I can compare this new model to the model I actually do own– the Minimed Paradigm 522. If I like the Revel, I can choose to upgrade my 522 for $400. I will be wearing the Revel for a number of weeks to get a better idea of its effect on my day-to-day life and my diabetes management. Here are some of the features that are new to the Revel: Predictive alerts: Whereas the Paradigm 522 would alert the user when her glucose levels were above or below certain thresholds, the Revel has predictive alerts that roughly anticipate when the user will pass a set threshold, and alert her a configured number of minutes beforehand with a message like “LOW PREDICTED.” Different alert thresholds for different times of the day: The Revel has slightly more flexibility than the Paradigm 522 when it comes to HIGH/LOW thresholds in that the user can set different thresholds according to the time of day. More verbose menu and action confirmation screens: The Revel boasts altered wording for some of the menu items that proved unclear to some users of the Paradigm 522 and older models, so, for example, the menu item “PRIME,” which reveals options for restarting the insulin reservoir, has been relabeled “RESERVOIR + SET.” Similarly, there are additional confirmation screens to ensure the user OKs certain procedural actions have been completed (for example, after filling the tubing, the user is asked, “DID YOU SEE DROPS AT END OF TUBING? YES/NO”). More graphs: With the Minimed CGM, the Revel can display o Continue reading >>

Medtronic Announces New Minimed 630g Insulin Pump System

Medtronic Announces New Minimed 630g Insulin Pump System

Today, Medtronic Diabetes announced their newest addition to their insulin pump lineup, the MiniMed 630G. So, what’s the same and what’s changed? Here are a few key features that remained the same, a few great new changes, as well as additions for this generation in the Medtronic family. The Familiar Threshold Suspend, Renamed: The new pump will carry over some familiar features such as the Threshold Suspend, now renamed SmartGuard Technology, Suspend on Low, and will use the same Enlite sensor technology that is used with the 530G edition. Predictive Alerts: It also holds the same Predictive Alerts technology, alerting patients to potential highs or lows before they happen. Supplies: The supplies will be the same so you can still use your same sensors, as well as cartridges and tubing. The Changes Orientation: The pump is now portrait-oriented for easier, one-handed holding and programming rather than landscape. Color Options: Medtronic usually has at least 5 options for colors, however, in this new addition to the “family,” there will only be one option–black. The user will have the option for colorful skins, both as stickers or rubber bumpers, so they can customize their pumps how they would like. User-Friendly Menus: The menus have been updated to be more user-friendly to help new users easily navigate and use the pump. Alarms: Another change is with the alerts and alarms. They are now very customizable, with options for audible or vibration alerts, and the audible alerts can be chosen based on tone volume. MiniMed Connect: Currently, due to different radio frequencies built into the 630G, patients will not be able to take advantage of the MiniMed Connect system with the new 630G. This may be a possibility in the future with further advancements. (The Mini Continue reading >>

670g And Me: Insights And Incites On Medtronic’s Latest System

670g And Me: Insights And Incites On Medtronic’s Latest System

What’s the purpose of a diabetes management device? Is it to lower A1c? Prevent hypoglycemia? Spend more time in-range? Some combination of all three? Or perhaps we have to look beyond blood sugar control. After all, quality of life has to count for something. Does it make living with diabetes safer and easier? My Detailed Review of The MiniMed 670G from Medtronic The MiniMed 670G from Medtronic is an insulin pump coupled with a glucose sensor. It uses a computer program (called an “algorithm”) to automate certain aspects of insulin delivery. I decided to try 670G partially out of professional interest (everybody and their great aunt has been asking for my opinion on the system), and partially out of personal interest, as my blood glucose control hasn’t been the greatest the past couple of years. Let me start out by saying this: Since I started using 670G, my overall blood glucose control is better. I have to keep reminding myself of this non-consequential fact, because every day I find things about this system that I don’t particularly like. In my opinion, the pump itself leaves a lot to be desired. There are so many features and so many menus and so many safety/confirmation steps that my button thumb is starting to form a blister. The color screen is nice, but not large enough to display everything it needs to display. And the freakin’ clip is upside down. The reservoir connector pokes me in the gut every time I bend over, and I have to unclip it to see the screen and programming menus in the proper orientation. The “hybrid closed loop” part of the system (what I prefer to call the “semi-automatic feature”) is what makes 670G special. It functions by making adjustments to the BASAL insulin based on data received from the linked glucose sensor. Sinc Continue reading >>

Minimed Paradigm

Minimed Paradigm

The Medtronic Minimed Paradigm 515 pump (RF receiver), Silhouette infusion set, and UltraLink blood sugar meter (RF transmitter). MiniMed Paradigm is a series of insulin pumps manufactured by Medtronic for patients with diabetes mellitus. The pump operates with a single AAA battery and uses a piston-plunger pump to infuse a programmed amount of insulin into the patient through a length of tubing. The Paradigm uses a one-way wireless radio frequency link to receive blood sugar measurements from select glucose meters. The Paradigm RT (Real Time) series adds the ability to receive data from a mated continuous blood-glucose monitor. Although the pump can use these measurements to assist in calculating a dose of insulin, no actual change in insulin delivery occurs without manual user-intervention. [1][2] In the United States, the device is regulated by a branch of the Food and Drug Administration.[3] Description[edit] Pump and infusion set (catheter) placement. Insulin basal bolus profile. Insulin pumps are drug delivery devices used to treat patients with type 1 and type 2 diabetes. The Minimed Paradigm REAL-Time and Continuous Glucose Monitoring (CGM) system, which received FDA clearance in 2006,[4] uses tubing and a reservoir with rapid-acting insulin. This "infusion set" is patient-connected via a catheter to the abdomen region. The infusion set can remain in the place for 3 days while the pump is clip-belt worn. There is a quick-disconnect feature for the tubing. The pump delivers insulin in two modes. In Basal rate mode, the delivery is continuous in small doses similar to a pancreas, for example 0.15 units per hour throughout the day. Basal rates are set to meet individual metabolic rates. In Bolus mode, the delivery is programmed to be a one-time delivery prior to ea Continue reading >>

Class 2 Device Recall Medtronic Minimed Paradigm Insulin Infusion Pumps

Class 2 Device Recall Medtronic Minimed Paradigm Insulin Infusion Pumps

Class 2 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps Class 2 Device Recall Medtronic MiniMed Paradigm Insulin Infusion Pumps Medtronic MiniMed Paradigm Insulin Infusion Pumps Model Numbers: MMT-511, MMT-512, MMT-712, MMT-712E, MMT-515, MMT-715, MMT-522, MMT-522K, MMT-722, MMT-722K, MMT-523, MMT-523K, MMT-723, MMT-723K, MMT-554, and MMT-754. Paradigm insulin infusion pumps are intended for use to deliver basal and bolus insulin to persons with diabetes. Medtronic is recalling the Medtronic Paradigm Insulin Pump because the pump's drive support cap may become detached from the pump case and protrude from the lower right side of the pump. When the pump is expose to water it may result in damage to the pump's internal electronics. This moisture damage can prevent the pump's buttons from working properly or can cause the pump to alarm. Medtronic sent an Urgent Medical Device Safety Notification letters to all affected customers. The recall letter informs the customers of the problem identified and the actions to be taken. The letter informs the healthcare professionals that Medtronic will inform their patients about the potential safety issues. Customers are instructed to find online information at www.medtronicdiabetes.com/support/product-updates. Customers are instructed to call Medtronic at 1.888.204.7616 (option 1 for loose drive support cap related questions and option 2 for water damage related questions). Distributors are instructed to provide Medtronic with an Excel spreadsheet list of all end users to whom they have shipped any of the listed serialized products. Worldwide Distribution - USA (nationwide) the countries of: AE, AR, AT, AU, BA, BH, BM, BR, BS, CA, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, DZ, EC, EE, EG, ES, FI, FR, GB, GR, GT, HK, HR, Continue reading >>

Downloading Your Medtronic Insulin Pump

Downloading Your Medtronic Insulin Pump

Carelinkâ„¢ Personal Download Reports 1. Getting Started: www.minimed.com --- Click on the Carelinkâ„¢ link 2. Register as a new user: 3. Go back in to www.minimed.com ---- Click on the Carelinkâ„¢ link 4. Sign in using your username and password 5. Order a Carelinkâ„¢ USB (the link will be on the lower right side.) If you have a Continuous Glucose Monitor or a Paradigm Revel insulin pump, you should have received the Carelink USB free with your device and will not need to order one. When you receive your Carelinkâ„¢ USB, you will be able to upload your pump 1. Return to www.minimed.com 2. Sign in using your username and password 3. Click on the Upload tab 4. Follow the instructions to upload your pump You can also refer to the Carelinkâ„¢ Personal Tutorial on-line at: After pump has been uploaded, click on the Reports tab 1. Quick View Summary for the last 2 weeks 2. Model day by hour 3. Logbook Diary 4. Sensor Daily overlay (for people with a CGM) 5. Sensor Daily overlay by meal Continue reading >>

Insulin Pump Rundown

Insulin Pump Rundown

Choosing an insulin pump doesn’t have to be an overwhelming process. Should you go with a more traditional pump where you can monitor your insulin levels directly? Are you looking for a model that works with a BGM monitor and allows you to administer insulin via a remote? Maybe you need a pump that offers integration with a CGM system. What about size? Color? To use tubes or not to use tubes? Presenting the options so you can find out what pump best fits your lifestyle is our goal. So, with several models on the market, let us help you sort through the choices by taking a look at what’s available and breaking down the various features of each. We’ve separated the pumps into four categories: pumps that incorporate or work with a Blood Glucose Monitor (BGM) and offer Continuous Glucose Monitoring (CGM), pumps with just CGM capability, pumps with just a BGM, and standalone pumps that don’t work with a BGM or offer CGM. Hybrid Closed-Loop System The 670 G system is the newest member to the Medtronic pump family and the first hybrid closed-loop system. In other ways, it is a like a “basal modulator” where you have to still bolus but it predicts your basal rate. Every 5 minutes, the auto-mode option (hybrid closed-loop) automatically adjusts basal insulin delivery based on your sugar levels to keep you range. It is excellent at catching lows because it stops your insulin dosage 30 minutes before you reach your pre-selected low limits, then it will automatically restart insulin when your levels recover. Possible concerns: excessive alerts and extended menu that needs clearing. Only approved for ages 14+ because it has a total daily dose requirement of at least 8 units a day. Feeling of loss of control of management with closed-loop system. Pumps with BGM and CGM ca Continue reading >>

Paradigm Revel 523/723

Paradigm Revel 523/723

The MiniMed Paradigm Revel System is their second generation integrated system. The system is setup to work as a standard insulin pump or with the Medtronic Continuous Glucose Monitor ( CGM ). The 2 devices communicate wirelessly. The CGM sends readings to the Revel pump every 5 minutes.There are two versions of the Revel, with the difference being the size of the reservior they can accomodate. The 523 uses only a 1.76 ml reservoir, while the 723 can use either 1.76 ml or a 3.0 ml reservoir. Bolus Wizard Calculator (based on fingerstick reading) predictive alerts to warn you up to 30 minutes before a low or high set different thresholds according to the time of day more graphs - 3, 6, 12, and 24 hour graphs lower minimum basal and bolus rates (as low as 0.025 units per hour) expanded insulin-to-carb ratio range (as low as 1 to 1) integrated with a CGM (additional purchase necessary) 5 colors availalble or customize yourself The MiniLink REAL-Time Transmitter attaches to your body separately from your infusion set and connects to the glucose sensor. The transmitter wirelessly sends glucose data from the glucose sensor to the insulin pump where it is updated and displayed every five minutes. The transmitter has a self-contained rechargeable battery that alerts you when it's getting low. The transmitter must be within 6 feet of the Revel pump for values to be continuously sent. An alert lets you know if you get out of range. If the pump and transmitter are out of range for an extended amount of time, the transmitter can hold up to 40 minutes of data. This data will be uploaded to the pump once they are back within range of each other. The MiniLink REAL-Time Transmitter and Charger both have a 6-month warranty. Existing, in-warranty MiniMed Paradigm Insulin Pump customers Continue reading >>

Up Close With Medtronic’s New Minimed 640g System In Europe

Up Close With Medtronic’s New Minimed 640g System In Europe

Twitter summary: Major updates from @MDT_Diabetes on the 640G predictive #insulin suspend for type 1 #diabetes from #ATTD2015 Medtronic Diabetes shared several exciting updates on its MiniMed 640G system and Enhanced Enlite CGM (“Enlite 2”) at this year’s ATTD Conference in Paris. The MiniMed 640G features “SmartGuard” technology, which will suspend insulin delivery if hypoglycemia is predicted to occur within 30 minutes (based on the CGM reading). The system automatically resumes insulin delivery once glucose levels start to recover. The MiniMed 640G is an exciting step beyond the MiniMed 530G/Veo, which could only suspend insulin delivery once hypoglycemia was reached, and it automatically stayed suspended for two hours (unless manually turned back on). The MiniMed 640G was launched in Australia this January, and is now also available in the UK and Denmark. An FDA submission of the system is expected later this year (the pivotal trial is ongoing), meaning the 640G could launch in the US sometime in 2016, although we think many things will need to go right to achieve this aggressive timeline. At ATTD, we had the opportunity to handle the new system ourselves and to hear new clinical trial data. Bottom line, hypoglycemia prevention is definitely the strong suit of the 640G, though the pump’s design improvements are an equally big win. We think it’s a particularly valuable option for those with hypoglycemia unawareness, a history of severe hypoglycemia, or who fear nighttime lows. diaTribe Plays with the 640G – Our Biggest Takeaways We got the chance to play with the 640G systems ourselves during a Medtronic workshop. Our key takeaways on the system’s design are: The 640G’s color, light-adjusting screen greatly improves the user experience. It’s not Continue reading >>

Medtronic Minimed Paradigm Insulin Pump - Review

Medtronic Minimed Paradigm Insulin Pump - Review

11- year-old Amelia McIver reviews the Medtronic MiniMed Paradigm insulin pump, which she uses without the Medtronic CGM. The pump has given her a lot of freedom! REVIEWER'S BREAKDOWN - PROs: choice of colors handy light makes it easy to bolus in the dark bolus wizard makes carb counting and dose setting easier features "square wave" and "dual wave" boluses for extended release (great for high-fat meals like pizza) easy to set temp basal rates for exercise or periods of inactivity Continue reading >>

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