FDAnews
www.fdanews.com/articles/88382-disetronic-medical-systems-recalls-d-tronplus-insulin-pump-power-packs-due-to-battery-design-issue

DISETRONIC MEDICAL SYSTEMS RECALLS D-TRONPLUS INSULIN PUMP POWER PACKS DUE TO BATTERY DESIGN ISSUE

July 14, 2006

Disetronic Medical Systems, based in Fishers, Ind., July 13 announced a voluntary nationwide recall of its D-TRONplus power packs for D-TRONplus insulin pumps.

There is a real potential for the power pack to shut the device down without warning, interrupting insulin delivery, the company said.

Such an interruption could lead to "uncontrolled diabetes mellitus, resulting in hyperglycemia, which may lead to serious patient injury and/or death," Disetronic said. This abrupt shutdown in the pump is due to a change in battery design by the battery manufacturer, which Disetronic would not name.

To view the recall notice, go to www.fda.gov/oc/po/firmrecalls/disetronic07_06.html (http://www.fda.gov/oc/po/firmrecalls/disetronic07_06.html).