Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The Food and Drug Administration (FDA) has issued a recall of some ACCU-CHEK Sprint insulin pumps manufactured by Disetronic Medical Systems Inc., to customers, distributors and health care professionals. The pumps may have a defect in the “up” and/or “down” buttons, which may present as an intermittent or complete loss of function of the buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. In the event of a failure, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged.

The recall notification applies to all ACCU-CHEK Sprint insulin pumps with serial numbers from SN02119552 through SN10006093. Disetronic says it has identified the root cause of the defect and is working to fix the problem. The company urges customers to continue to use their ACCU-CHEK Sprint insulin pumps but to monitor the functioning of the “up” and “down” buttons. Customers also are being asked to monitor their blood glucose as directed by their healthcare professional.

If the vibration or acoustic confirmation signal does not occur, the user should disconnect the pump and switch to a back up pump or an alternative method of insulin delivery. Immediately contact ACCU-CHEK Spirit hotline for a replacement pump or for any other questions regarding this potential defect. Customers should expect the replacement pump within 1-2 business days after contacting ACCU-CHEK Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.

This entry was posted on Tuesday, May 5th, 2009 at 7:00 am and is filed under product liability. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.