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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

Disetronic Medical Systems Inc Announces a Voluntary Nationwide Recall of Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps

Contact:
Lori LeRoy
317-521-7159

FOR IMMEDIATE RELEASE -- July 13, 2006 -- Fishers, Indiana -- 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 injury and/or death. This is an Urgent Device Correction notification to health care professionals and their patients not requiring product removal at this time.

The abrupt shutdown of the D-TRONplus insulin pump is due to a change in the battery design by its manufacturer. As a result, the pump does not have enough time to recognize a decrease in the power supply, which causes the pump to shut down before the audible and vibrating low power alarms are triggered.

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 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.

Disetronic and their distributors will also provide every user with a new power pack every two weeks. Distribution of these power packs will begin on Thursday, July 13, 2006.

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. Disetronic has tested the replacement design being shipped and we have data to verify a two week use period in the pumps without failure.

If you are a physician or a patient who has experienced a problem with any Disetronic D-TRONplus Power Packs, please notify Disetronic at 1-800-688-4578.

An interruption in insulin delivery may lead to uncontrolled diabetes mellitus, resulting in hyperglycemia, which can lead to serious patient injury and/or death. The symptoms of hyperglycemia may include nausea/vomiting, blurred vision, excessive thirst or hunger, frequent urination, fatigue/tiredness/sleepiness, headache, fruity acetone breath, abdominal pain, and coma. 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. Disetronic is notifying by direct mail affected customers, healthcare providers and its distributors of this action.

This recall is being conducted with the knowledge of the U. S. Food and Drug Administration.

Any adverse reactions or adverse events experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website.

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