LONDON (dpa-AFX) - Medtronic plc, an Irish healthcare technology company, is recalling its MiniMed 600 series or 700 series insulin pumps citing potential risks of shortened pump battery life.
The U.S. Food and Drug Administration or FDA has classified the action as a class I recall, which has been initiated after the firm received 170 reports of hyperglycemia >400mg/dL and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US.
The company said it has 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. They are required to contact the firm if observing changes in the battery life of their pump.
Medtronic said the investigation on the issue began after receiving customer reports of shortened battery life. As per a comprehensive analysis, 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.
According to the firm, 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 or DKA, potentially requiring medical intervention.
Medtronic noted that 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. Users should be prepared to replace the battery as soon as the 'Low Battery Pump' alarm sounds.
Further, the company urges the users to always carry an extra set of new AA lithium or alkaline batteries or fully charged NiMH batteries if in case they need to replace the battery sooner than expected.
Customers, who experience any issues, are asked to contact their local Medtronic team to determine whether a replacement pump is needed.
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