Accu-Check Spirit Insulin Pumps RecalledMay 1, 2009 | Parker Waichman LLP
Accu-Check Spirit insulin pumps are being recalled by Disetronic Medical Systems Inc., a unit of the Roche Group, because of a potential defect in the “up” and/or “down” buttons of some devices. According to the recall notice, if the buttons do not function, users may not be able to change any programmed setting on the Accu-Check Spirit insulin pumps.
“We are making this proactive notification to our customers and other interested parties because we have seen a potential for the “up” and/or “down” buttons on some of our pumps to fail over a period of use,” Dr. Mathias Neumann, Head of Global Quality Management Diabetes Care, Roche Diagnostics, said in a statement released by the company. “We are telling our customers to continue to use their ACCU-CHEK Spirit insulin pumps, but monitor the functioning of the “up” and “down” buttons. In addition customers are to continue to monitor their blood glucose as directed by their healthcare professional."
The recall involves Accu-Check Spirit insulin pumps with serial numbers in the range from SN02119552 through SN10006093 (US market). The potentially defective buttons are used to override pre-programmed settings or to deliver an additional bolus dose of insulin.
To determine if an Accu-Check Spirit insulin pump is defective, patients should test the up and down buttons to see if they can change the programmed setting on the pump. Defective pumps may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. If such a signal doesn't occur, the user should disconnect the pump and switch to a back-up pump or an alternative method of insulin delivery, and immediately call the Accu-Check hotline for a replacement pump.
Customers should expect a replacement pump within 1-2 business days after contacting Accu-Check Spirit hotline at 1-800-778-5095. This number is available 24 hours a day, 7 days a week.
According to the recall notice, the root cause of the defect has been identified. The problem is an interrupted electronic contact in the flexible board of the “up” and “down” button module caused over time by stress of this board during repeated pressing of the button. A fix to the problem has been implemented for Accu-Check Spirit insulin pumps with SN10006094 and above.
Pumps with serial numbers including and above SN10006094 are not affected and no action is required by users of these pump.