Accu-Chek Spirit Recall
Late this afternoon the FDA announced a recall of the Accu-Chek Spirit insulin pump. According to the announcement:
“Disetronic Medical Systems Inc. announced today that it is notifying its customers, distributors and healthcare professionals about a potential defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin 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.”
The announcement goes on to state; “Disetronic will replace pumps within the affected serial numbers (SN02119552 to SN10006093) that have intermittent or complete loss of function of the “up” and/or “down” button promptly upon contact from the customer with a new pump that is not affected by the potential button failure.”
This recall is just more bad news for Roche’s struggling insulin pump unit and couldn’t have come at a worse time for the company. Although Diabetic Investor did not expect Roche to garner a large share of the now abandoned Cozmo users, Smiths Medical decision to exit the insulin pump market did create a possible opportunity for the company to gain new users.