Dive Brief:
- Medtronic has notified customers that battery issues with its Minimed 600 and 700 series insulin pumps could cause the devices to stop delivering insulin significantly sooner than expected.
- A “low battery pump” alert, intended to signal up to 10 hours of remaining battery life, may be displayed on the device even if much less time is left, the October correction update said. Medtronic told customers they could contact the company to determine the need for a replacement pump.
- Medtronic said it received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis in the U.S., from January 2023 to September 2024, potentially related to the issue.
Dive Insight:
Medtronic first alerted customers to a problem with the pumps’ battery status display in July. It found some pumps that were dropped or bumped may have damage to internal electrical components that could reduce battery life.
The company initiated a recall on July 31 for more than 785,000 devices. The Food and Drug Administration labeled the recall a Class I event, the severest classification. Medtronic said in its July notice that no serious injuries were confirmed due to the issue.
The October update includes information on reports received by Medtronic and encourages customers to contact the company to determine if a replacement pump is needed.
Medtronic emphasized that users should always carry extra batteries and backup insulin therapy and noted that dropping the pump even once could result in reduced battery life, either immediately or over time. The problem could continue after replacing the battery.
Escalating alerts and sirens may activate after the “low battery pump” alert. When the “replace battery now” alarm appears, insulin delivery stops. “Do not wait for the later battery alerts as these may occur when less battery life remains than the User Guide states,” the company said.
Pump models including the Minimed 630G, 670G, 770G and 780G systems are affected by the notice.
In April 2023, the Food and Drug Administration lifted a two-year-old warning letter tied to problems with the retainer rings for Medtronic’s MiniMed 600 series insulin pumps that could result in incorrect insulin dosing. The warning letter said the company did not properly classify risk to patients and initiate a recall, despite thousands of medical device reports related to the problem.