By Tara Dairman | May 8, 2009 2:57 pm
On April 30, Disetronic Medical Systems, Inc. (a division of Roche) announced a recall of certain Accu-Chek Spirit insulin pumps due to a manufacturing problem: These pumps may be at risk of having their "up" and/or "down" buttons fail with repeated use. Pumps with serial numbers ranging from SN02119552 to SN10006093, which were shipped in the United States, are affected by this recall.
If a pump’s “up” or “down” buttons are defective, it may stop functioning intermittently or completely, in which case pump users may not be able to change any programmed settings on the pump. If the buttons are not working properly, the user will not receive a confirmation signal (a vibration or sound), and the display on the pump will not change when he uses the buttons.
If this failure occurs, users should disconnect the pump and switch to an alternate method of insulin delivery (a backup pump or injections). Then they should call the Accu-Chek Spirit hotline to request a replacement pump, which should arrive in 1–2 business days. The hotline number is (800) 778-5095, and it is available 24 hours a day, 7 days a week.
To learn more about this situation, visit the U.S Food and Drug Administration’s (FDA) page or Disetronic’s page about the recall. You can also call the hotline number above with any questions.
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