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Urgent Recall - Medtronic Minimed Infusion Sets

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 part of the recall, and which are not. The following link will tell you how to have any recalled infusion sets replaced by Medtronic. It also contains 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 will replace any recalled sets free of charge. Medtronic has advised that replacement infusion sets are made with new and enhanced materials which reduce the risk of insulin over-delivery after an infusion set change. Diabetes Australia, as the administrator of the NDSS, will be directly writing to people who have purchased Medtronic infusion sets since July 2016. The National Diabetes Services Scheme (NDSS) is an initiative of the Australian Government administered with the assistance of Diabetes Australia. Continue reading >>

Medtronic Recalls Diabetes Infusion Sets

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 >>

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

DH notified of recall of specific lots of MiniMed Infusion Sets Hong Kong (HKSAR) - The Department of Health (DH) today (September 12) received notification from medical device manufacturer Medtronic Hong Kong Medical Limited (Medtronic) on its voluntary recall of specific lots of MiniMed Infusion Sets due to a potential safety concern. According to the information provided by Medtronic, the MiniMed Infusion Sets are used with Medtronic insulin pumps. Medtronic has recently received reports of potential over-delivery of insulin after changing of infusion set. The manufacturer's investigation revealed that the problem could 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 insulin reservoir which can then prevent the infusion set from working properly. The manufacturer said that new infusion sets currently being shipped contain an enhanced membrane material that can significantly reduce the risk concerned. While patients with new and enhanced infusion sets that are not part of the recall can continue to use their sets, those who are using the infusion sets being recalled should carefully follow the key steps regarding the priming/fill-tubing process as advised by the manufacturer before they can obtain new sets. "Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. We noted that the manufacturer has received relevant reports of hypoglycemia requiring medical intervention overseas. So far, the DH has not received any reports of adverse incidents related to the affected lots of infusion sets in Hong Kong," a spokesman for the DH said. Patients using the affected devices should visit the manufacturer's Continue reading >>

Medtronic - Il Mio Diabete

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 Product Recall

Medtronic Product Recall

Medtronic has placed a recall on insulin pump infusion sets. This voluntary recall is the result of the discovery of potential overdose when the site is inserted. Reports quote the Medtronic Diabetes CMO stating that there is a potential for a complication to occur when a membrane that’s used to release pressure from inside the pump gets wet and blocks the vents. The risk of an excessive insulin dose is greatest right after the patient changes the infusion set, which is done every three days, she said. According to Medtronic, the reported incidence rate requiring medical assistance related to this issue is less than 1 in every 2 million infusion sets. Medtronic is replacing any sets that are affected, and they have set up a website that you can use to check. No matter what country you live in, you should confirm if any of your sets are part of the recall. We have checked, and the process is easy. Unfortunately all of our sets need to be replaced, but we are pleased that Medtronic has disclosed this and they will replace any recalled sets for free. The letter from Medtronic can be found here. To see if your sets are in the recall, visit Continue reading >>

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

Dh Notified Of Recall Of Specific Lots Of Minimed Infusion Sets

DH notified of recall of specific lots of MiniMed Infusion Sets DH notified of recall of specific lots of MiniMed Infusion Sets *************************************************************** The Department of Health (DH) today (September 12) received notification from medical device manufacturer Medtronic Hong Kong Medical Limited (Medtronic) on its voluntary recall of specific lots of MiniMed Infusion Sets due to a potential safety concern. According to the information provided by Medtronic, the MiniMed Infusion Sets are used with Medtronic insulin pumps. Medtronic has recently received reports of potential over-delivery of insulin after changing of infusion set. The manufacturer's investigation revealed that the problem could 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 insulin reservoir which can then prevent the infusion set from working properly. The manufacturer said that new infusion sets currently being shipped contain an enhanced membrane material that can significantly reduce the risk concerned. While patients with new and enhanced infusion sets that are not part of the recall can continue to use their sets, those who are using the infusion sets being recalled should carefully follow the key steps regarding the priming/fill-tubing process as advised by the manufacturer before they can obtain new sets. "Over-delivery of insulin can cause hypoglycemia and in extreme cases, death. We noted that the manufacturer has received relevant reports of hypoglycemia requiring medical intervention overseas. So far, the DH has not received any reports of adverse incidents related to the affected lots of infusion sets in Continue reading >>

Meditronic Recalls Diabetes Infusion Sets |

Meditronic Recalls Diabetes Infusion Sets |

in Dangerous & Defective Devices , Defective Product , Personal Injury Medtronic Recalls Diabetes Infusion Sets Due to Risk of Overdose Medtronic PLC has announced that it has issued a recall of a disposable device in its insulin pumps. Medtronic claims that it has discovered the disposable part can release too much of the drug, which may put patients at risk of hypoglycemia. In cases of severe hypoglycemia, an individual needs immediate medical attention. Seizures, convulsions, an inability to eat or drink, and a loss of consciousness may result. According to Medtronic, roughly 1 in every 2 million infusion sets manufactured before April of 2017 may be at risk of malfunctioning. The malfunction results when a membrane that is used to release pressure from the interior of the pump gets wet. The membrane then blocks the vents. The risk of an insulin overdose is greatest right after the patient changes the infusion set. Patients must change their infusion sets every three daysthus, the risk is quite high. Francine Kaufman, the chief medical officer of Medtronics diabetes group, commented, Shortly after that change, the patient could experience insulin over-delivery. Kaufman claims that there have not been any deaths associated with the defective device. Fortunately, many individuals realized their blood sugar was too low and were able to remedy the condition. Some sought emergency medical treatment. Those whose devices were made since April need not worry, the company claims. The matter has allegedly been resolved by Medtronic. Those who do have defective devices may have them replaced by Medtronic at no cost. Patients can go to checklots.medtronicdiabetes.com to see if their devices are affected. Medical device companies must be held accountable when their products are Continue reading >>

Medtronic Insulin Pump Lawsuits

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 Recall Specific Lots Of Infusion Sets With All Models Of Medtronic Insulin Pumps

Medtronic Recall Specific Lots Of Infusion Sets With All Models Of Medtronic Insulin Pumps

Medtronic has started to inform patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The 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 can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycaemia. Currently manufactured infusion sets, available from April 2017, include a design update of this component which the company believes reduces the above risk. 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 and will continue working directly with government and regulatory authorities on this global voluntary recall. Customer Instructions Medtronic recommends that customers use only infusion sets made with the new and enhanced component, the membrane, starting with their next set change. Customers in the United States can determine if they have recalled infusion sets by visiting Customers in Europe, Middle East and Africa (EMEA region) can determine if they have recalled infusion sets by visiting www.mmc.medtronic-diabetes.com/look. Medtronic also advise that patients can always consult the advice of their healthcare professional regarding their medical treatment. Continue reading >>

Caremark

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 >>

Sou Doce: O Recall Da Medtronic

Sou Doce: O Recall Da Medtronic

A Medtronic anunciou emsetembro um recall em lotes especficos dos conjuntos de infuso da bomba deinsulina. Eu vi essa notcia no Facebook e no dei muita importncia no. Orecall era mundial. Em outubro, recebi 3 cartas daMedtronic informando sobre o recall e ento eu decidi verificar os lotes das 4caixas que eu tinha aqui em casa. Resultado: todas elas estavamno recall e precisam ser trocadas. Fiquei desesperada. Srio, meucho caiu e eu no sabia o que fazer. Como posto mensalmente aqui noblog, h muitos meses eu no recebo o conjunto de infuso da secretaria desade. Para compensar, eu acabo usando cada cateter por 4 ou 5 dias (eucoloco insulina no reservatrio para que dure por 4 dias, s vezes, eu utilizomenos insulina, consequentemente, o reservatrio acaba durando 5 dias. Mas esse o mximo de tempo que uso o mesmo cateter e quase nunca chega a durar 5dias). Assim, vou fazendo minha reserva de conjunto de infuso, uma vez que otratamento de alto custo e no consigo comprar os insumos que faltam todos osmeses. Que falta de sorte a minha emter 4 caixas reservas, no perodo em que eu no estou recebendo os insumos etodas as 4 estarem no recall. A primeira coisa que conseguipensar foi: vou comprar uma caixa e ir me virando com ela, at a Medtronictrocar as outras 4. Liguei no 0800 e quase choreiao telefone quando a atendente falou que a caixa com 10 unidades aumentou paraR$ 813,00!!! Fiquei sem fala. Comprei, a contragosto. O 0800 tem uma opo parafalar somente sobre o recall, a opo 4, que nunca atende. Ento eu apertoqualquer outro nmero (2 ou 3) e peo para me transferirem. Consegui, com muito custo,falar com algum sobre o recall. Me explicaram o seguinte: > Eu tinha 4 caixas fechadas e 1aberta, em uso, que estavam no lote do recall; >Dentro de 15 dias teis, apartir daquela ligao, a Medtr Continue reading >>

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets (mdt.n)

Medtronic Announces Voluntary Recall Of Diabetes Infusion Sets (mdt.n)

Medtronic Announces Voluntary Recall of Diabetes Infusion Sets (MDT.N) DUBLIN - September 11, 2017 - Medtronicplc (NYSE:MDT) announced today that it has started to informpatients worldwide of a voluntary recall of specific lots ofinfusion sets used with all models of Medtronic insulin pumps. Therecall is related to a certain discontinued component in theseinfusion sets and does not include insulin pumps or glucosesensors. The company determined, through recentfield reports from patients and root cause analysis, that acomponent, the vent membrane, in the recalled infusion sets may besusceptible to being blocked by fluid during the process ofpriming/fill-tubing. This situation can lead to potentialover-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 ofthis component which the company believes reduces the risk ofinsulin over-delivery after an infusion set change. The companywill work with patients to ensure recalled infusion sets with thediscontinued component are returned and replaced with new infusionsets containing the updated component at no cost. Medtronic has contacted the U.S. Foodand Drug Administration (FDA), along with other regulatory bodiesaround the world, to share information related to this issue.Medtronic will continue working directly with government andregulatory authorities on this global voluntary recall. "Our priority is to work with ourpatients to mitigate risk to patient safety. While we have shippeda significant number of the new and enhanced sets since April, weare committed to replacing recalled infusion sets for allpatients," said Francine Kaufman, M.D., chief medical officer ofthe Diabetes Group at Medtroni Continue reading >>

Medtronic Minimed Infusion Sets

Medtronic Minimed Infusion Sets

URGENT MEDICAL DEVICE RECALL INFORMATION Because the safety of our customers is our top priority, we are voluntarily recalling specific lots of infusion sets used with Medtronic insulin pumps. Explanation of the Issue 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. Actions Required by You 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. Your REF and LOT numbers are listed on the labels as shown in the examples below: 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 priming/fill-tubing process. If you only have recalled infusion sets right now, it is very important that you carefully follow the Key Steps. Return your recalled infusion sets within the next four weeks the pre-paid label that has been sent to you. Medtronic will replace the recalled infu Continue reading >>

Nightscout/intend-to-bolus

Nightscout/intend-to-bolus

Discussions around DIY closed looping with #OpenAPS you have to cd ~/myopenaps/ before doing any openaps commands. if you did any openaps init outside that, you may need to rm -rf ~/.git/ to clean that up @scottleibrand good afternoon. I am so sad, the monster treatment in futur is back, which was a few days before, for example. Corretur Bolus 11.4 in 2076 by delay Pumphistory*.json does not solve the problem @scottleibrand I see the timestamp is wrong, e.g. 2021, 2070, 2076 etc. How can fix it? the monster futur treatments reupload without end I use an iphone with OpenAPS and have used BT tethering without fail until a few days ago. My phone still shows it connecting to the rig (the blue bar appears), but the rig doesn't actually connect to the internet. I've re-ran the BT setup process and everything seems to work up until I try testing it. When I run ifconfig bnep0, i get this: [email protected] :~# sudo dhclient bnep0 bnep0 Link encap:Ethernet HWaddr 58:a8:39:01:14:0b UP BROADCAST RUNNING MULTICAST MTU:1500 Metric:1 RX packets:1 errors:0 dropped:0 overruns:0 frame:0 TX packets:3 errors:0 dropped:0 overruns:0 carrier:0 RX bytes:55 (55.0 B) TX bytes:60 (60.0 B) there doesn't seem to be any actual internet connection wondering if this is an issue with my setup or something that could be wrong with my phone. nothing has changed since the time it worked correctly after Reinstall would be totally catastrophe with me @Kdisimone Thanks, Katie. As it turned out, the problem was more interesting. A couple of years ago I bought my first G4 and tried to buy supplies from Dexcom - they wouldn't sell anything to me. I had opened an account, then forgot it. My G5 data was going to that account. Now fixed and NS is working. :) Good to hear @daveklingler My next suggestion was to try logg Continue reading >>

Tga - Therapeutic Goods Administration (via Public) / Medtronic Minimed Infusion Sets

Tga - Therapeutic Goods Administration (via Public) / Medtronic Minimed Infusion Sets

09/15/2017 | News release | Distributed by Public on 09/14/2017 22:39 Consumers and health professionals are advised that Medtronic Australasia, in consultation with the TGA, is recallingspecific lots of Medtronic MiniMed infusion sets, including MiniMed Quick-set, MiniMed mio, MiniMed Silhouette and MiniMed Sure-T. Medtronic MiniMed infusion sets are used in conjunction with an insulin pump to deliver a continuous dose of insulin to help people with diabetes maintain normal blood glucose levels. There have been recent reports of potential over-delivery of insulin shortly after an infusion set change. Over-delivery of insulin can cause hypoglycaemia (low blood glucose level), which can lead to serious health complications. 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. Updated infusion sets contain a new and enhanced membrane material that significantly reduces this risk. People who have Medtronic MiniMed infusion sets are instructed to check the lot numbers either by visiting a Medtronic website or by calling Medtronic to see if their products are affected (see the 'Information for consumers' or 'Information for health professionals' sections below for further details). 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 us Continue reading >>

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