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Disetronic D-Tronplus Power Packs

Disetronic Medical Systems Inc. (Disetronic) announced on July 13, 2006 a nationwide recall of the Disetronic D-TRONplus Power Packs, which powers the D-TRONplus Insulin Pump. This action has been taken because of the power pack can shut down the D-TRONplus Insulin Pump without any warning. If an insulin pump automatically shuts off, the distribution of insulin to the patient is stopped. A disturbance of insulin delivery can cause uncontrolled diabetes mellitus, causing hyperglycemia, and then patients might suffer serious injuries or even death. The symptoms of hyperglycemia can include:

• Nausea/vomiting
• Blurred vision
• Excessive thirst or hunger
• Frequent urination
• Fatigue
• Tiredness
• Sleepiness
• Headache
• Fruity acetone breath
• Abdominal pain
• Coma

The unexpected shutdown of the D-TRONplus insulin pump is the result of a change in the battery design by its manufacturer. Therefore, the defect in the pump does not have adequate time to identify a decrease in the power supply, which causes the pump to shut down before the audible and vibrating low power alarms are activated. Until further notice 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 this 2-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. This is a temporary fix to the power pack problem until adequate supplies of the corrected battery can be obtained. We will update all users when the problem is resolved.

Patients experiencing these symptoms are advised to check their blood glucose level to ensure that they are within acceptable ranges as defined by their healthcare team. Patients are advised to contact their health care provider if they have questions. Users of the D-TRONplus pumps should monitor pumps closely to ensure adequate delivery of insulin. Clinicians should exercise maximum vigilance in monitoring patients, in the event of any of the aforementioned signs or symptoms.

Disetronic D-TRONplus Power Packs are available by prescription only for diabetes patients who use insulin pump therapy.

If you or a loved one suffered injuries from a Disetronic D-TRONplus Power Pack, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney.