Medtronic, which develops, manufactures and sells medical remedy units, has issued a voluntary recall of its MiniMed 600 sequence or 700 sequence insulin pumps because of the pump’s probably shortened battery life.
The corporate issued a discipline motion, beginning on July 31, notifying prospects globally that they need to monitor their MiniMed pump’s built-in alarms and alerts to maintain observe of battery standing and speak to the corporate in the event that they discover modifications within the pump’s battery life.
Medtronic mentioned 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 on account of harm to the gadget’s inside electrical elements.
“This electrical challenge additionally causes battery alerts to happen when much less battery life stays than the Consumer Information states. This may increasingly end result within the pump stopping insulin supply considerably earlier than normally anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), probably requiring medical intervention,” the corporate mentioned in an announcement.
“Most lately, Medtronic has acquired 170 stories of hyperglycemia >400 mg/dL and 11 stories of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. probably associated to this challenge.”
The FDA categorised the difficulty as a category I recall, which is essentially the most severe sort of recall, that means there’s a affordable probability that utilizing the product might lead to severe damage or loss of life.
The corporate mentioned the pump would nonetheless generate battery alerts and alarms, however they’d not be delivered “with the same old quantity of battery life remaining earlier than the battery should be changed to keep away from the pump stopping insulin supply.”
Medtronic mentioned customers ought to exchange the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they must be changed earlier than anticipated, and have a backup remedy in case it’s wanted.
The Dublin-based firm mentioned no matter whether or not the pump has skilled a drop or one other bodily affect, customers who expertise a major lower in battery life ought to contact the corporate to find out if a substitute pump is required.
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