Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets
DUBLIN - September 11, 2017 - Medtronic plc announced today that it has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. Check your set number here - You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. The company will work with patients to ensure recalled infusion sets with the discontinued component are returned and replaced with new infusion sets containing the updated component at no cost. Medtronic has contacted the U.S. Food and Drug Administration (FDA), along with other regulatory bodies around the world, to share information related to this issue. Medtronic will continue working directly with government and regulatory authorities on this global voluntary recall. "Our priority is to work with our patients to mitigate risk to patient safety. While we have shipped a significant number of the new and enhanced sets since April, we are committed to replacing recalled infusion sets for all patients," said Francine Kaufman, M.D., chief medical officer of the Continue reading >>
Medtronic Australasia Pty Ltd — Medtronic Minimed Infusion Sets Including Minimed Quick-set, Minimed Mio, Minimed Silhouette And Minimed Sure-t (specific Lots)
What are the defects? There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Subsequent investigations have found that this issue may be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol or water is spilled on the top of the reservoir or inside the tubing connector, which could prevent the insulin set from working properly. What should consumers do? Medtronic Australasia has written to consumers who have Medtronic MiniMed infusion sets to provide further information about this issue, include details of the recall procedure and instructions regarding the priming/fill-tubing process (called 'Key Steps'). If you or someone you provide care for uses Medtronic MiniMed infusion sets, go to (link is external) to determine if the infusion sets you have are affected by this recall. If you have affected infusion sets, follow the instructions on the website to arrange replacements. You will need to enter the REF and LOT numbers for all infusion sets you have. See the attached photographs of the box and pouch labels for the location of the REF and LOT numbers. Alternatively, you can call Medtronic on 1800 777 808 (press option 1). Unless you do not have access to a suitable alternative, do not use infusion sets that are affected by this recall. If you are unable to access infusion sets that are not affected by this recall, you can use the recalled products but must carefully follow the 'Key Steps' provided in the recall letter. This information is also available at (link is external). Alternatively, if you do not feel comfortable using these products, you can choose to revert to your back-up injection plan until your replace Continue reading >>
Medtronic Insulin Pump Lawsuits
Drug Dangers Defective Medical Devices Medtronic Insulin Pump Lawsuits The Medtronic insulin pump is a medical device that makes it easier and more convenient to receive a daily dose of insulin. It consists of a small box about the size of a cell phone which can be kept in the pocket or worn on a belt. The pump delivers insulin through an infusion set which is connected to a cannula placed under the skin of the abdomen. In addition to making insulin administration more convenient, the Medtronic MiniMed insulin pump system provides a continuous supply of insulin which is intended to closely match the function of a healthy pancreas. The pump can also deliver on-demand or preprogramed boluses of insulin based on diet and blood sugar demands. In a person with a healthy pancreas, the body naturally produces insulin to utilize sugar absorbed in the diet and maintain energy levels. In people with diabetes, this system does not function correctly. In type 1 diabetes, the pancreas cannot make insulin and replacement therapy must be used. Type 2 diabetics may be able to secrete insulin, but the body does not respond to it as it should. They may be unable to make enough, or body cells have become resistant. In some cases, diet and medications may be sufficient to control blood sugar but in other cases, insulin therapy may be required. When a diabetic is insulin dependent, he or she must supply the body with insulin from an outside source usually an injection. For patients who use insulin injections, sometimes multiple daily injections are required to control blood sugar. The pump has replaced the needs for many people, providing a more convenient and hygienic method for insulin administration. Unfortunately, some Medtronic insulin pump users have experienced insulin overdose due Continue reading >>
Medtronic Nslin Pompas Nfzyon Setlerini Geri Aryor
Medtronic nslin Pompas nfzyon Setlerini Geri aryor Medtronic Diyabetin global bir arsn sizlerle paylamak istedik. Ama ncelikle kk bir not: Bu konu sadece Trkiye ile ilgili deil, byk apta ve global bir durum. Medtronic inslin pompas kullanan biz diyabetlilerin bu srete sakin ve lml olmas gerekiyor. Medtronic Trkiye Diyabet Blm mutlaka gerekli hazrl yapmtr ama bizlerin de bu srete hem lml hem sakin hem de zm odakl olmamz lazm. Medtronic Trkiye Diyabet Blmne de iki yolla, telefon ya da mail, ulaabiliyorsunuz. Bu srete illaha telefonla ulaacam diye kendinizi yormayn. nk herkes bir endie ile ulama telanda olacak. [email protected] mail adresinden daha hzl ve pratik ulaabileceini belirtmek isterim. nslin pompas set deiimini yaptktan ksa bir sre sonra rezervuardan daha fazla inslin gitmesi gibi teknik bir sorun tespit edilmi. Ve fazladan inslin gitmesi ile de birka hipoglisemi vakalaryla karlalm. Medtronic Diyabet Blm de globalde bu sorunu kendileri tespit ederek ve gnll olarak FDAe bildirmi. Medtronic Trkiye Diyabet Blm de Salk Bakanlna bu konuyu bildirmi durumda. Bildiiniz gibi Medtronic inslin pompalarnda rezervuara inslin ektikten sonra rezervuarn inesini karnda birka damla inslin grnebiliyor. Ya da rezervuar pistonun altnda pistonun kenarlarna inslin girebiliyor. Bu ekilde bir durum olutuunda rezervuarn iinde fazla basn olumakta ve infzyon seti de bu basnc dengeleyememekte. Set hazrl yaparken de setin ucundan inslin ktnda ya pskrerek kabiliyor ya da sanki bir sorun yokmu gibi vcudumuza takyoruz ve seti taktktan 1-2 saat sonra o fazla basn cilt altna fazla inslin gnderebiliyor. Bu sebeple de Medtronic belirlenen LOT numarasna sahip infzyon setlerini geri aryor. Medtronic Trkiye Diyabet Blm Ne Yapacak? u anda Salk Bakanlna konu bildirilmi durumda. Trkiyedeki tm Medtron Continue reading >>
Product Recall: Medtronic Minimed Infusion Sets
Medtronic has announced a voluntary recall of their Medtronic MiniMed Infusion Sets. Why? There have been reports of over-delivery of insulin following infusion set changes. These occurrences of over-delivery of insulin can cause hypoglycemia, some cases being extreme and needing medical intervention. Medtronic states: Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. What You Can Do You can go to to see if you have recalled infusion sets. You’ll need to enter the REF and LOT numbers, which can be seen in this illustration, highlighted by the red boxes. Enter in the numbers for all of the infusion sets that you have to see if they are affected. Medtronic states not to use any of the infusion sets on the list. More Questions? Follow the process on the website at You can call Medtronic at 1.888.204.7616. You can also report an adverse event to the FDA’s MedWatch Adverse Event Reporting program: Report by telephone: 1.800.FDA.1088 Fax report: 1.800.FDA.0178 Continue reading >>
Caremark
Here at CVS/caremark, were dedicated to delivering the highest level of pharmacy care and take a proactive stance on drug safety alerts. We have a dedicated Drug Safety Alert team monitoring the U.S. Food and Drug Administration (FDA) website, as well as all other manufacturer and pharmacy communications, to ensure that all the products we dispense are safe and effective. One component of Drug Safety Alerts is product recalls. The FDA defines a product recall as actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative or by FDA request. There are two levels of recalls that impact CVS/caremark: i. Patient Level: the recall applies to patients or consumers and pharmacies. ii. Retail Level: the recall applies to pharmacies and healthcare providers that stock the recalled product. It does not include patients or consumers. Based on the FDA guidelines, in the case of a patient-level recall, action is immediately taken to remove the affected products from distribution and notify any members who may be at risk. In the case of a retail-level recall, action is immediately taken to remove the affected products from distribution. For additional information regarding safety alerts, visit the U.S. FDA website . Continue reading >>
Caremark
Here at CVS/caremark, were dedicated to delivering the highest level of pharmacy care and take a proactive stance on drug safety alerts. We have a dedicated Drug Safety Alert team monitoring the U.S. Food and Drug Administration (FDA) website, as well as all other manufacturer and pharmacy communications, to ensure that all the products we dispense are safe and effective. One component of Drug Safety Alerts is product recalls. The FDA defines a product recall as actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative or by FDA request. There are two levels of recalls that impact CVS/caremark: i. Patient Level: the recall applies to patients or consumers and pharmacies. ii. Retail Level: the recall applies to pharmacies and healthcare providers that stock the recalled product. It does not include patients or consumers. Based on the FDA guidelines, in the case of a patient-level recall, action is immediately taken to remove the affected products from distribution and notify any members who may be at risk. In the case of a retail-level recall, action is immediately taken to remove the affected products from distribution. For additional information regarding safety alerts, visit the U.S. FDA website. Continue reading >>
Medtronic: Verifica Dei Set Di Infusione Del Microinfusore Dinsulina
Medtronic ha annunciato oggi di aver iniziato a informare i pazienti in tutto il mondo circa un richiamo volontario di particolari lotti di set di infusione utilizzati con tutti i modelli di pompe di insulina Medtronic. Il richiamo correlato a un determinato componente interrotto in questi gruppi di infusione e non include pompe per insulina o sensori di glucosio. Lazienda ha determinato la causa principale del predetto problema, attraverso lanalisi dai recenti rapporti sul campo riportati dai pazienti, che un componente, la membrana di sfiato, nei set di infusione richiamati pu essere suscettibile di essere bloccato dal fluido durante il processo di innesco del riempimento del serbatoio. Questa situazione pu portare a una sovradosaggio potenziale dellinsulina poco dopo il cambio del set di infusione, che pu causare ipoglicemia. I set di infusione attualmente prodotti, disponibili per i pazienti dallaprile del 2017, includono un aggiornamento di progettazione di questo componente che la societ ritiene riduca il rischio di sovradosaggio di insulina dopo il cambio del set di infusione. Lazienda lavorer con i pazienti per garantire che i set di infusione richiamati con il componente interrotto siano restituiti e sostituiti con nuovi set di infusione contenenti il ??componente aggiornato senza alcun costo. Medtronic ha contattato lUS Food and Drug Administration (FDA), insieme ad altri organismi regolatori di tutto il mondo, per condividere le informazioni relative a questo problema. La priorit lavorare con i nostri pazienti per attenuare i rischi nella sicurezza del paziente. Mentre abbiamo spedito un numero significativo di set nuovi e migliorati da aprile, siamo impegnati a sostituire i set di infusione richiamati per tutti i pazienti, ha affermato il Dr. Francine Kaufm Continue reading >>
Medtronic Minimed Infusion Set Recall
Infusion sets connect an insulin pump to the body of a person with type-2 diabetes. Medtronic has become aware of reports of potential over-delivery of insulin shortly after an infusion set change. The problem is that a vent membrane in some of the sets could be blocked by fluid. These blockages may occur during the process of pump priming (or removal of air bubbles) and fill-tubing. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. If the vent membrane is blocked, it could potentially result in over-infusion of insulin. Over-delivery of insulin can cause extremely low blood-sugar levels (hypoglycemia) and death in extreme cases. Medtronic has received reports of hypoglycemia that may be linked to the blocked vent membrane. Some patients required medical intervention. In response, Medtronic has discontinued the affected vent membranes in the infusion sets. Francine Kaufman, chief medical officer of Medtronics diabetes group, recommended that customers use only infusion sets made with the new and enhanced membrane. Infusion sets manufactured after April 2017 include a design update that Medtronic believes reduces the risk of insulin over-delivery after an infusion set change. Customers in the U.S. can determine if they have recalled infusion sets by visiting . You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. If you have additional questions, please call Medtronic at 1-888-204-7616. Continue reading >>
News - Local News: Sudbury News, Suffolk, Best Site For What's On, Events And News (sudbury)
"A great venue with fabulous Events, recommended " "Is really good to see that a local daily news and whats on site has been launched in Sudbury, well done Nick" Medtronic recall MiniMed infusion sets following reports of over-delivery of insulin in Sudbury Medtronic recall MiniMed infusion sets following reports of over-delivery of insulin The following notice has been issued by the manufacturer: Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Medtronic has become aware of recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. Medtronic has received reports of hypoglycemia requiring medical intervention potentially related to this issue. Our investigation has shown this can be caused by fluid blocking the infusion set membrane during the priming/fill-tubing process. A membrane blocked by fluid most likely occurs if insulin, alcohol, or water is spilled on top of the insulin reservoir which then could prevent the infusion set from working properly. Infusion sets currently being shipped by Medtronic contain a new and enhanced membrane material that significantly reduces this risk. Go to to determine if you have recalled infusion sets. You will be prompted to enter the REF and LOT numbers for all infusion sets in your possession. The website will then tell you which infusion sets are part of this recall and which are not. Medtronic recommends you not use recalled infusion sets. If you have new and enhanced infusion sets that are not part of this recall, use only those sets starting with your next set change. As a reminder, we have Key Steps regarding the pri Continue reading >>
Medtronic - Il Mio Diabete
Medtronic Minimed 670G porta benefici a giovani ed adulti con diabete tipo 1: lo dicono gli endocrinologi USA Il sistema di infusione per insulina MiniMed 670G (Medtronic, Northridge, California) pu migliorare i risultati glicemici nei bambini con diabete di tipo 1 a partire dai 7 anni di et, secondo uno studio finanziato dall'industria. I risultati sono stati presentati in un poster sabato 17 Continua a leggere Il nuovo set dinfusione Medtronic MiniMed Mio Advance con un ago invisibile Largomento lo abbiamo gi trattato con un recente articolo: Medtronic sta introducendo un nuovo set di infusione che affronta alcune delle sfide legate all'uso dei prodotti correnti, inclusa la paura dell'ago. Molti diabetici che fanno insulina tramite impiego di microinfusore possono avere Continua a leggere Medtronic: il nuovo sensore Enlite 3 rende praticamente perfetto il dato glicemico al pari del prelievo dal sangue capillare Medtronic riceve l'approvazione della FDA per inserimento nel braccio del nuovo sensore Guardian (TM) 3 - Ulteriore miglioramento dell'esperienza a ciclo chiuso ibrido MiniMed (TM) 670GMedtronic leader mondiale nella tecnologia medica, ha annunciato oggi che la Food and Drug Administration (FDA) Continua a leggere Medtronic presenta il set di infusione Advance MiniMed (TM) Mio (TM) per persone affette da diabete DUBLINO - 21 febbraio 2018 -Medtronic leader mondiale nella tecnologia, nei servizi e nelle soluzioni mediche, ha presentato oggi il set di infusione MiniMed (TM) Advance.Il set di infusione MiniMed Mio Advance la nuova aggiunta al portafoglio MiniMed di set di infusione e Continua a leggere Medtronic: verifica dei set di infusione del microinfusore dinsulina DIABETEASYper partecipare clicca quiMedtronic ha annunciato oggi di aver iniziato a informare Continue reading >>
Medtronic Issues Wide-ranging Infusion Set Recall
9/11/2017 – 12:30 pm (EST) – This story has been updated. On September 11th, Medtronic issued a notice stating that the company is voluntarily recalling certain lots of infusion sets used with all models of its insulin pumps. The recall covers all lots of Medtronic infusion sets sent to customers before April 2017, except for its infusion sets with luer locks during that time period; this exception was first reported by Diabetes Mine and has been confirmed by Medtronic. The recall also may affect some lots of infusion sets shipped after April 2017. A Medtronic press release states that the recall involves a discontinued component that has since been replaced in infusion sets currently being sold by Medtronic. Medtronic undertook the recall after field reports suggested that a vent membrane in the infusion set could become blocked by fluid during the priming and filling process. This can increase the risk for overdelivery of insulin during pump use, which could in turn increase the risk of hypoglycemia in the pump user, according to the press release. Currently, Medtronic has only received reports of this happening in one out of every 2 million infusion sets in use, but that ratio very well might go up somewhat as news of the recall spreads. sponsor Medtronic reports that it has developed a membrane design update which the company believes will reduce the risk of overdelivery of insulin after a set change. This update was phased into infusion set lots shipped after April 2017. The company states it will replace infusion sets covered by the recall free of charge, and it discourages customers from using infusion sets from lots listed in the recall. In the FAQ section about the recall, the company states users should consider using multiple daily injections while waitin Continue reading >>
Urgent Recall - Medtronic Minimed Infusion Sets
Medtronic, in consultation with the Therapeutic Goods Administrations (TGA), has issued a global recall of some infusion sets used with Medtronic insulin pumps. This recall was initiated following recent reports of the potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia. To determine if you have any recalled infusion sets go to The website will prompt you to enter the REF and LOT numbers for all of the infusion sets in your possession. You will then be told which of the infusion sets are included in the recall, and which are not. If you have any recalled infusion sets, please complete the online form. To ensure that your replacement request is processed, make sure you click the SUBMIT button once your form is complete. Once the online form is submitted, replacement box/es of infusion sets will be sent by Medtronic directly to your nominated delivery address, free of charge. Please cut-out and retain the barcodes on your recalled infusion set boxes. These should be placed in the reply-paid envelope that will be included in the delivery of the replacement infusion sets. Send this envelope back to Medtronic but do not return the recalled infusion sets. You can dispose of your recalled infusion sets once you have returned the barcode to Medtronic. The following link contains more information on the recall, including important safety information about avoiding potential insulin over-delivery: Please do not use any of the recalled infusion sets. If necessary, please make use of your diabetes self-management back-up plan as agreed with your health professional until Medtronic are able to replace your recalled products. Medtronic has advised that replacement infusion sets are made with new and enhanced materi Continue reading >>
Diabetes Equipments, Insulin Pump, Multiple Daily Insulin Injections, Type 1 Diabetes, Glucose Monitoring Systems
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. Continue reading >>
- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
- NIHR Signal Insulin pumps not much better than multiple injections for intensive control of type 1 diabetes
- End of daily injections for diabetes as scientists restore insulin production
Medtronic Recalls Diabetes Infusion Sets
Medtronic is recalling specific lots of infusion sets used with all models of its insulin pumps. The vent membrane in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing, leading to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia. Currently manufactured infusion sets, available to patients since April 2017, include a design update of this component which the company believes reduces the risk of insulin over-delivery after an infusion set change. What to do Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. U.S. customers can determine if they have recalled infusion sets by visiting Customers outside the U.S. will receive instructions specific to their country. U.S. customers who have experienced an issue with the use of a Medtronic infusion set may report it to the firm's 24-hour helpline at +1-800-204-7616. Continue reading >>
