Disetronic Medical Systems recalls insulin pumps
Device Regulation Alert: Safety, Compliance and Reimbursement News, May 9, 2009
Disetronic Medical Systems issued a recall for its ACCU-CHEK Spirit insulin pumps with serial numbers from SN02119552 through SN10006093 because the “up” and “down” buttons are potentially defective, according to a company release.
Patients use the pump’s “up” and “down” buttons to change the program in the menu or to administer additional insulin. If the buttons do not function, users may not be able to change any programmed setting on the pump.
Disetronic will replace pumps within the affected serial numbers that have intermittent or complete loss of function of the “up” and/or “down” button. Disetronic discovered the problem through the company’s normal quality control monitoring process.
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