Recall (field corrective action) - Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump
MedSun: Newsletter #37, June 2009

FDA Website

Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the "up" and/or "down" buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the "up" and/or "down" buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.

Additional Information:

FDA Press Release. Disetronic Medical Systems Inc. (a member of the Roche Group) announces a recall (field corrective action) of the ACCU-CHEK® Spirit insulin pump due to “up” and/or “down” button failures. April 30, 2009.
http://www.fda.gov/Safety/Recalls/ucm144111.htm


MedSun Newsletters are available at www.fda.gov/cdrh/medsun