Medtronic, which 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 doubtlessly shortened battery life.
The corporate issued a subject 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 get in touch with 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 impression even as soon as, they skilled a shortened battery life both instantly after the drop or over time resulting from injury to the machine’s inside electrical parts.
“This electrical concern additionally causes battery alerts to happen when much less battery life stays than the Person Information states. This will consequence within the pump stopping insulin supply considerably earlier than often anticipated and will result in well being dangers like hyperglycemia or diabetic ketoacidosis (DKA), doubtlessly requiring medical intervention,” the corporate stated in a press release.
“Most just lately, Medtronic has acquired 170 experiences of hyperglycemia >400 mg/dL and 11 experiences of diabetic ketoacidosis from January 2023 to September 2024 within the U.S. doubtlessly associated to this concern.”
The FDA categorized the difficulty 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 may lead to critical harm or loss of life.
The corporate stated 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 stated customers ought to exchange the battery as quickly because the “Low Battery Pump” alarm sounds, carry an additional set of batteries ought to they should be changed earlier than 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 impression, customers who expertise a major lower in battery life ought to contact the corporate to find out if a alternative pump is required.
