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Disetronic D-Tronplus Power Packs
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
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.
Disetronic D-Tronplus Power PacksRSS Feed
Disetronic Medical Systems Inc Announces a Voluntary Nationwide Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps
Jul 13, 2006 | www.fda.gov
Disetronic Medical Systems Inc. (Disetronic) of Fishers, IN announced today a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, that power the D-TRONplus Insulin Pump. There is the real 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...
Defective Medical Devices
Quick Facts
Disetronic D-Tronplus Power Packs Reference Guide
Manufacturer
Disetronic Medical Systems
Status
Recall July 13, 2006 Approved Uses
Delivers insulin to abdominal
Complications
Manufacturing Problems
Diabetes mellitus
Hyperglycemia
Death Related Topics
Disetronic H-Tron Insulin Pump
Defective Medical Devices
Disetronic Medical Systems
Status
Recall July 13, 2006 Approved Uses
Delivers insulin to abdominal
Complications
Manufacturing Problems
Diabetes mellitus
Hyperglycemia
Death Related Topics
Disetronic H-Tron Insulin Pump
Defective Medical Devices
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