July 14, 2006 -- Disetronic Medical Systems today issued an urgent product recall for its Disetronic D-TRONplus Power Packs, which power its D-TRONplus Insulin Pump.
The voluntary recall is just for the power pack, not the insulin pump itself.
The recalled power packs "have a potential to shut down the pump without warning," states Disetronic Medical Systems' recall notice, which is posted on the FDA's web site.
If the power pack shuts down, patients may experience serious or even fatal side effects, the company warns, adding that the problem is due to a battery design change made by the battery's maker.
Disetronic Medical Systems is shipping new power packs, free of charge, to all D-TRONplus users until the problem has been corrected.
Changing Power Packs
Meanwhile, the company urges patients to keep using their insulin pump but to monitor it closely and to change the power pack every two weeks, with no exceptions.
"Until further notice, you must put a new power pack into your insulin pump every two weeks to prevent your pump from turning off without any warning," states the product recall. "It is important that you do not extend the two-week period."
Disetronic Medical Systems says the solution is temporary and that it will notify all users when the situation is resolved. Meanwhile, doctors or patients who have problems with the recalled power packs should call Disetronic Medical Systems Pump Support at (800) 688-4578.
If the pump's insulin delivery is interrupted, patients should follow their doctor's advice about alternative insulin delivery methods and blood glucose monitoring. Patients should then notify their doctor, call 911, or go to an emergency room as soon as possible, the company states.