Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps
Audience: Endocrinologists, other healthcare professionals, and consumers
[UPDATE 09/20/2006] Recall classified as Class I because the potential of the pump's power pack to fail may cause serious adverse health consequences, including death.
[Posted 07/14/2006] Disetronic Medical Systems Inc. (Disetronic) and FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning. If a shut down occurs, insulin delivery is interrupted. An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death.
All pump users must put a new power pack into their insulin pump every two weeks to prevent their pump from turning off without any warning. It is important that this two week period not be extended. Disetronic and their distributors will supply power packs free of charge by UPS next day shipment to all D-TRONplus users until corrective actions have been implemented. Every user will receive a power pack together with detailed instructions.