FDA insulin pump alert


Intravenous products: The July FDA Patient Safety News Alert describes that “Disetronic Medical Systems is notifying healthcare professionals and patients about a possible defect with the some of the company’s ACCU-CHEK Spirit insulin pumps. The defect can cause the “up” and “down” buttons on these pumps to stop working, either completely or intermittently. These buttons are used to change the pump programming or to administer additional insulin through a bolus delivery. So if they do not work, pump users may not be able to change any of the pump’s programmed settings.

When the buttons are pushed, the pump normally responds with a confirmation signal: a sound, a vibration, or both. If the buttons stop working, the signal will not occur, and the pump display will not change. If pump users cannot confirm that a change was made, they should disconnect the pump and switch to a back-up pump or other insulin delivery method. Then they should immediately contact the company’s hotline to get a replacement pump. If the buttons on the pump continue to work, the company says the pumps can still be used, but users should make sure the “up” and “down” buttons are working, by verifying that they get a confirmation signal after each pump operation”.

For more information call the ACCU-CHEK Spirit hotline. That number is 1-800-778-5095.

Click here for the full FDA alert.


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