Medtronic has issued a second alert letter to patients regarding shortened battery life of the MiniMed 600 and 700 series insulin pumps.
The affected products include the MiniMed 630G, 670G, 770G, and 780G, all lots and serial numbers. The problem can arise when a pump is dropped, bumped, or otherwise physically impacted so as to damage the electrical components. This can lead to an increased risk for reduced battery life and less time until shutdown after the pump issues a battery alert. Thus, the pump may stop insulin delivery significantly sooner than the user expects.
The US Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type. However, it doesn’t necessitate immediate removal of all products. Users were told to contact Medtronic if they experience significantly reduced battery life to determine whether replacement is necessary.
The new alert updates a previous one issued in July. On October 4, 2024 (and announced by FDA on October 17), the company issued an “Urgent Medical Device Correction” letter, advising users to do the following:
- Carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries in case a battery change is needed sooner than expected.
- Pay attention to all pump alerts and alarms.
- Replace the battery as soon as you receive the “Low Battery Pump” alert.
- Do not wait for later battery alerts, as these may occur when less battery life remains than noted in the User Guide.
- Refer to the User Guide for instructions on how to replace the battery.
- Be aware that when the “Replace Battery Now” alarm appears, insulin delivery stops.
- Contact Medtronic 24-Hour Technical Support team at 1-800-378-2292 to determine whether a replacement pump is needed if the pump exhibits any significant decrease in battery life, whether or not the pump has been dropped, bumped, or experienced other physical impacts.
- Have back-up insulin therapy available at all times in your emergency kit.
From January 2023 to September 2024, Medtronic reported receiving 170 reports of hyperglycemia above 400 mg/dL, and 11 reports of diabetic ketoacidosis related to this issue. There have been no reports of death.
Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape, with other work appearing in the Washington Post, NPR’s Shots blog, and Diatribe. She is on X (formerly Twitter) @MiriamETucker.
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Publish date : 2024-10-17 19:46:46
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