Voluntary recall notifying Medtronic insulin pump users of potential risks of shortened pump battery life
Medtronic (NYSE: MDT) has issued a voluntary recall for its MiniMed™ 600 and 700 series insulin pumps due to potential risks of shortened battery life. The recall, initiated on July 31, 2024, urges users to monitor built-in alerts and alarms for battery status and contact Medtronic for replacements if battery life issues are observed. The issue stems from internal electrical component damage caused by drops or impacts, leading to premature battery depletion. This can result in the pump stopping insulin delivery earlier than expected, posing health risks like hyperglycemia or diabetic ketoacidosis (DKA). From January 2023 to September 2024, there were 170 reports of hyperglycemia and 11 reports of DKA in the U.S. related to this issue. The FDA has classified this recall as a class I recall. Medtronic advises users to carry extra batteries and contact support if they notice significant battery life reduction.
Medtronic (NYSE: MDT) ha annunciato un richiamo volontario per le sue pompe per insulina MiniMed™ delle serie 600 e 700 a causa di potenziali rischi di riduzione della durata della batteria. Il richiamo, avviato il 31 luglio 2024, invita gli utenti a monitorare gli avvisi e gli allarmi integrati per lo stato della batteria e a contattare Medtronic per sostituzioni se si osservano problemi di durata della batteria. Il problema deriva da danni ai componenti elettrici interni causati da cadute o impatti, che portano a una scarica anticipata della batteria. Questo può provocare l'interruzione della somministrazione di insulina prima del previsto, comportando rischi per la salute come iperglicemia o chetoacidosi diabetica (DKA). Da gennaio 2023 a settembre 2024, ci sono stati 170 rapporti di iperglicemia e 11 rapporti di DKA negli Stati Uniti correlati a questo problema. La FDA ha classificato questo richiamo come un richiamo di classe I. Medtronic consiglia agli utenti di portare batterie extra e di contattare il supporto se notano una significativa riduzione della durata della batteria.
Medtronic (NYSE: MDT) ha emitido un retiro voluntario para sus bombas de insulina MiniMed™ de las series 600 y 700 debido a posibles riesgos de reducción de la vida útil de la batería. El retiro, iniciado el 31 de julio de 2024, insta a los usuarios a monitorear las alertas y alarmas incorporadas sobre el estado de la batería y a contactar a Medtronic para reemplazos si se observan problemas de duración de la batería. El problema se origina por daños en los componentes eléctricos internos causados por caídas o impactos, lo que lleva a una descarga prematura de la batería. Esto puede resultar en que la bomba detenga la entrega de insulina antes de lo esperado, lo que representa riesgos para la salud como hiperglucemia o cetoacidosis diabética (DKA). Desde enero de 2023 hasta septiembre de 2024, hubo 170 informes de hiperglucemia y 11 informes de DKA en EE. UU. relacionados con este problema. La FDA ha clasificado este retiro como un retiro de clase I. Medtronic aconseja a los usuarios que lleven baterías adicionales y que contacten al soporte si notan una reducción significativa en la duración de la batería.
Medtronic (NYSE: MDT)는 배터리 수명 단축의 잠재적 위험으로 인해 MiniMed™ 600 및 700 시리즈 인슐린 펌프에 대한 자발적 리콜을 발표했습니다. 2024년 7월 31일에 시작된 이번 리콜은 사용자가 배터리 상태에 대한 경고 및 알람을 모니터링하고 배터리 수명 문제가 관찰될 경우 Medtronic에 교체를 요청하도록 권장합니다. 이 문제는 낙하 또는 충격으로 인한 내부 전기 부품 손상에서 비롯되며, 이로 인해 배터리가 조기에 소모될 수 있습니다. 이로 인해 펌프가 예상보다 일찍 인슐린 공급을 중단할 수 있으며, 이는 고혈당증이나 당뇨병성 케톤산증(DKA)과 같은 건강 위험을 초래할 수 있습니다. 2023년 1월부터 2024년 9월까지 이 문제와 관련하여 미국에서 고혈당증 170건, DKA 11건의 보고가 있었습니다. FDA는 이 리콜을 클래스 I 리콜로 분류했습니다. Medtronic은 사용자가 여분의 배터리를 지참하고 배터리 수명이 급격히 줄어들 경우 지원팀에 문의할 것을 권장합니다.
Medtronic (NYSE: MDT) a émis un rappel volontaire de ses pompes à insuline MiniMed™ des séries 600 et 700 en raison de risques potentiels de réduction de la durée de vie de la batterie. Le rappel, initié le 31 juillet 2024, invite les utilisateurs à surveiller les alertes et alarmes intégrées concernant l'état de la batterie et à contacter Medtronic pour des remplacements si des problèmes de durée de vie de la batterie sont observés. Le problème provient de dommages causés aux composants électriques internes par des chutes ou des impacts, entraînant une décharge prématurée de la batterie. Cela peut entraîner l'arrêt de l'administration d'insuline plus tôt que prévu, posant des risques pour la santé tels que l'hyperglycémie ou l'acidocétose diabétique (DKA). Entre janvier 2023 et septembre 2024, il y a eu 170 rapports d'hyperglycémie et 11 rapports de DKA aux États-Unis liés à ce problème. La FDA a classé ce rappel comme un rappel de classe I. Medtronic conseille aux utilisateurs d'emporter des batteries supplémentaires et de contacter le support s'ils constatent une réduction significative de la durée de vie de la batterie.
Medtronic (NYSE: MDT) hat einen freiwilligen Rückruf für seine MiniMed™ 600 und 700 Serien Insulinpumpen aufgrund potenzieller Risiken einer verkürzten Batterielebensdauer herausgegeben. Der Rückruf, der am 31. Juli 2024 eingeleitet wurde, fordert die Benutzer auf, eingebaute Warnungen und Alarme zum Batteriestatus zu überwachen und Medtronic für Ersatz zu kontaktieren, wenn Probleme mit der Batterielebensdauer festgestellt werden. Das Problem resultiert aus Schäden an internen elektrischen Komponenten, die durch Stürze oder Stöße verursacht werden und zu einer vorzeitigen Entleerung der Batterie führen. Dies kann dazu führen, dass die Pumpe die Insulinabgabe früher als erwartet stoppt, was Gesundheitsrisiken wie Hyperglykämie oder diabetische Ketoazidose (DKA) mit sich bringen kann. Von Januar 2023 bis September 2024 gab es in den USA 170 Berichte über Hyperglykämie und 11 Berichte über DKA, die mit diesem Problem in Zusammenhang stehen. Die FDA hat diesen Rückruf als Rückruf der Klasse I eingestuft. Medtronic rät den Benutzern, zusätzliche Batterien dabei zu haben und den Support zu kontaktieren, wenn sie einen signifikanten Rückgang der Batterielebensdauer bemerken.
- None.
- Potential health risks like hyperglycemia and DKA due to premature battery depletion.
- 170 reports of hyperglycemia and 11 reports of DKA from January 2023 to September 2024.
- The FDA classified the recall as a class I recall, indicating a high risk to health.
Insights
This voluntary recall by Medtronic for their MiniMed 600 and 700 series insulin pumps is a significant issue for diabetic patients and the company. The potential for shortened battery life due to physical impact could lead to unexpected insulin delivery interruptions, posing serious health risks like hyperglycemia and diabetic ketoacidosis (DKA).
Key points to consider:
- The FDA has classified this as a Class I recall, the most serious type, indicating potential for severe health consequences.
- Medtronic reported 170 cases of hyperglycemia and 11 cases of DKA potentially related to this issue over 21 months in the US alone.
- The company is proactively replacing affected pumps, which could impact their financials and market share in the competitive insulin pump market.
- This recall may lead to increased scrutiny of Medtronic's quality control processes and could affect consumer trust in their products.
For investors, this situation warrants close monitoring of Medtronic's handling of the recall, potential legal liabilities and the impact on their diabetes business segment performance in upcoming quarters.
This recall presents significant financial and reputational risks for Medtronic's diabetes business. Key financial implications include:
- Recall Costs: Expenses related to pump replacements, customer support and potential compensation could be substantial.
- Revenue Impact: Possible slowdown in new pump sales as consumers may hesitate to purchase affected models.
- Market Share: Competitors like Tandem Diabetes Care and Insulet could gain market share if Medtronic's reputation is damaged.
- Legal Liabilities: Potential for lawsuits related to reported hyperglycemia and DKA cases.
Medtronic's diabetes segment accounted for
Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue
GALWAY,
Medtronic issued an updated notification to customers stating the following:
- Even a single drop of the pump could result in reduced battery life, either immediately after the drop, or over time, and the issue will continue even after replacing the battery.
- The pump will still generate battery alerts and alarms, but these alerts and alarms may not be delivered with the usual amount of battery life remaining before the battery must be replaced to avoid the pump stopping insulin delivery. Be prepared to replace the battery as soon as the "Low Battery Pump" alarm sounds.
- Users should always carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries should they need to replace the battery sooner than expected.
- Users who notice a significant decrease in battery life from their usual experience, regardless of whether their pump has been dropped, bumped, or has experienced physical impact, should contact their local Medtronic team to determine whether a replacement pump is needed. Customers in the
U.S. can call 1-800-378-2292 for 24-hour technical support. Customer outside theU.S. can click on this link to find the number for their local support team. - Users are advised to have a back-up therapy available in case it's needed.
''Medtronic began proactively notifying impacted pump users in July because of the high priority we place on patient safety and understand the important role of pumps in the care and management of diabetes," said Robert Vigersky, MD, Chief Medical Officer, Medtronic Diabetes. "Our team is here 24 hours a day, 7 days a week to help if you experience battery depletion or any other issue with your pump. Patient safety is our priority, as is continuity of therapy, which is why we made the decision to voluntarily notify patients and will replace pumps when needed."
The original notification and the updated notification are available on the Medtronic Diabetes website.
About the Diabetes Business at Medtronic (www.medtronicdiabetes.com)
Medtronic is working together with the global community to change the way people manage diabetes. The company aims to transform diabetes care by expanding access, integrating care and improving outcomes, so people living with diabetes can enjoy greater freedom and better health.
About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Galway,
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
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SOURCE Medtronic plc
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