Medtronicwhich develops, manufactures and sells medical remedy gadgets, 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 area 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 call 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 as a consequence of injury to the system’s inside electrical elements.
“This electrical concern additionally causes battery alerts to happen when much less battery life stays than the Person Information states. This may occasionally consequence within the pump stopping insulin supply considerably prior to often anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), probably requiring medical intervention,” the corporate mentioned in a press release.
“Most just lately, Medtronic has obtained 170 reviews of hyperglycemia >400 mg/dL and 11 reviews of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. probably associated to this concern.”
The FDA categorised the problem as a category I recall, which is probably the most critical kind of recall, which means there’s a affordable likelihood that utilizing the product might end in critical damage or demise.
The corporate mentioned the pump would nonetheless generate battery alerts and alarms, however they’d not be delivered “with the standard 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 substitute the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they have to be changed prior to 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 alternative pump is required.
