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[IP] Fw: FDA MedWatch - Recall Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps: Potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning



----- Original Message -----
From: CDER MEDWATCH LISTSERV
To: email @ redacted
Sent: Friday, July 14, 2006 12:08 PM
Subject: FDA MedWatch - Recall Disetronic D-TRONplus Power Packs used in
D-TRONplus Insulin Pumps: Potential that the power pack could shut down the
D-TRONplus Insulin Pump without any warning


MedWatch - The FDA Safety Information and Adverse Event Reporting Program

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.

Read the complete MedWatch 2006 Safety summary, including links to the firm
press release, and the Disetronic Medical Systems Inc. Urgent Product Recall
notice, at:

http://www.fda.gov/medwatch/safety/2006/safety06.htm#DTRONplus




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