April 30, 2009
Some Disetronic insulin pumps are recalled
The U.S. Food and Drug Administration announced a recall of Accu-Chek Spirit insulin pumps due to a potential malfunction.
The FDA said Disetronic Medical Systems Inc. is recalling pumps with serial numbers from SN02119552 through SN10006093. The company said it took the action after identifying a potential defect in the
down buttons of some insulin pumps.
The failure, the FDA said, might present as an intermittent or complete loss of function of the
down buttons that are used for changing the program in the menu or to administer additional insulin through a bolus delivery. If the buttons do not function, users may not be able to change any programmed setting on the pump.
If the failure occurs, the pump might not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged, the FDA said. The defect was discovered through the company's normal quality control monitoring process. Officials said the defect has been corrected in pumps with serial numbers of SN10006094 and above.
People using the pumps can obtain further information from the company at 800-778-5095.