NOTICE: This is a beta website for the Department of Developmental Services (DDS). Please visit the current DDS Website.

Search Department of Developmental Services - Beta Filtered Topic Search
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
Medical Device Advisory
The FDA Safety Information and Adverse Event Reporting Program - MedWatch released the following information:
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 
Please ensure those responsible are aware of this medical device advisory.  Per the direction of the DDS Director of Health Services all agencies (public and private) should forward this information to their nursing staff.  Any questions regarding this medical device advisory should be directed to David Carlow, DDS Director of Health Services at (860) 418-6083.