Medtronic, which develops, manufactures and sells medical remedy units, has issued a voluntary recall of its MiniMed 600 collection or 700 collection insulin pumps because of the pump’s doubtlessly shortened battery life.
The corporate issued a discipline motion, beginning on July 31, notifying clients globally that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain monitor of battery standing and speak to the corporate in the event that they discover adjustments within the pump’s battery life.
Medtronic stated it started analyzing its pump’s battery life after receiving buyer complaints that if the pump was bumped, dropped or had any bodily affect even as soon as, they skilled a shortened battery life both instantly after the drop or over time as a consequence of harm to the machine’s inner electrical elements.
“This electrical difficulty additionally causes battery alerts to happen when much less battery life stays than the Consumer Information states. This will outcome within the pump stopping insulin supply considerably ahead of often anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), doubtlessly requiring medical intervention,” the corporate stated in an announcement.
“Most just lately, Medtronic has obtained 170 stories of hyperglycemia >400 mg/dL and 11 stories of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. doubtlessly associated to this difficulty.”
The FDA categorised the problem as a category I recall, which is probably the most severe sort of recall, that means there’s a cheap probability that utilizing the product may end in severe damage or dying.
The corporate stated the pump would nonetheless generate battery alerts and alarms, however they might not be delivered “with the same old quantity of battery life remaining earlier than the battery have to be changed to keep away from the pump stopping insulin supply.”
Medtronic stated customers ought to substitute the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they should be changed ahead of anticipated, and have a backup remedy in case it’s wanted.
The Dublin-based firm stated no matter whether or not the pump has skilled a drop or one other bodily affect, customers who expertise a big lower in battery life ought to contact the corporate to find out if a substitute pump is required.
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