Safety Report: Medtronic MiniMed series insulin pumps - recalled due to Defect, USA

United States

Medtronic plc voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 series insulin pumps to follow their pump’s built-in alerts and alarms for battery status and to contact Medtronic if they observe changes in the battery life of their pump. Most recently, Medtronic has received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US potentially related to this issue.

Medtronic began investigating this issue upon receiving customer reports of shortened battery life and a comprehensive analysis found that pumps that have been dropped, bumped, or experienced physical impact even once may result in shortened battery life due to damage to internal electrical components. This electrical issue also causes battery alerts to occur when less battery life remains than the User Guide states. This may result in the pump stopping insulin delivery significantly sooner than usually expected and could lead to health risks like hyperglycemia or diabetic ketoacidosis (DKA), potentially requiring medical intervention.

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.
- Users are advised to have a back-up therapy available in case it’s needed.

Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact company for pump replacement if affected by this issue

In case you experience issue from this product, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance.

Company name: Medtronic plc
Brand name: Medtronic
Product recalled: MiniMed™ 600 series or 700 series insulin pumps
Reason of the recall: Device & Drug Safety - Defect
FDA Recall date: October 18, 2024

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/voluntary-recall-notifying-medtronic-insulin-pump-users-potential-risks-shortened-pump-battery-life