|TO:||DDS Regional Directors, STS Director, CTH Coordinators, Private Providers, CO Quality Management Personnel|
|FROM:||David Carlow, Director, Health Services|
|DATE:||May 4, 2009|
|RE:||MEDICAL DEVICE ADVISORY: FDA MedWatch - Disetronic ACCU-CHEK Spirit Insulin Pump - Defect in the up/down buttons, may result in users unable to change programmed settings|
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