Disetronic Medical Systems Inc.
Accu-Chek Spirit insulin pump
Disetronic Medical Systems Inc. (a member of the Roche Group) announced a recall (field corrective action) of the ACCU-CHEK Spirit insulin pump due to ''up'' and/or ''down'' button failures.
This notification applies to all ACCU-CHEK Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 (range of SN shipped to the US). Pumps with serial numbers including and above SN10006094 are not affected and no action is required by users of these pumps.
This failure may present as an intermittent or complete loss of function of the ''up'' and/or ''down'' buttons. The pump's ''up'' and ''down'' buttons 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 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. This defect was discovered through the company's normal quality control monitoring process.
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