Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump
Audience: Diabetes healthcare professionals, patients
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.
Read the complete MedWatch 2009 Safety summary, including a link to the firm's press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit
