Tuesday, August 16, 2005

Product Recall - Insulin Pump Adapter

On July 29, Disetronic Medical Systems recalled its D-Tron adapter - for use with the D-Tron and D-TronPlus insulin pumps, and the Accu-Chek D-TronPlus insulin pump.
(A DTronPlus insulin pump is shown. The clear plastic adapter can be seen attached to the right of the pump.)

According to Disetronic:
"Use of the recalled adapter may result in the over delivery of insulin of up to 1.8 units of insulin." This "may pose a potentially life-threatening situation to children using the pump."

Overdelivery of insulin can result in hypoglycemia or low blood glucose. Anyone who requires a small amount of daily insulin or who is insulin sensitive and uses this adapter may be at risk for this condition.

Disetronic has manufactured new adapters. In the meantime, they recommend you inspect your adapter package before use. The affected adapter is marked as Part # REF 3000803. Their website has posted the old, recalled package label (left) and their new package label (right):


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For information regarding replacement of affected D-TRON adapters:
Contact the Disetronic Pump User Support Group at 1-800-688-4578.

For Disetronic's recall notice:
URGENT PRODUCT RECALL: Potential Life-Threatening Situation to Children Using the Pump

For the FDA's press release on the recall:
Disetronic Medical Systems, Inc. Announces a Voluntary Recall of the D-TRON Adapters, Used With the D-TRONplus Insulin Pump