Roche Diagnostics Australia Pty Limited—Accu-Chek Spirit Combo Insulin Pump
What are the defects?
In a small percentage of Accu-Chek Spirit Combo insulin pumps, a faulty component in the vibration alarm may generate an error message ('E7: ELECTRONIC ERROR') and an audible signal at pump start up. If this occurs, it will prevent the pump from operating.
What are the hazards?
Potential for delay to treatment in rare cases.
What should consumers do?
If you have an Accu-Chek Spirit Combo insulin pump with a serial number between 10171897 and 10281629, you should have received a letter from Roche Diagnostic Australia with information about this issue.
If you experience an 'E7: ELECTRONIC ERROR', you should attempt to clear it by following the instructions in the operator's manual:
•remove or disconnect the infusion set from the infusion site
•replace the battery in the pump
•prime the infusion set
•reconnect the infusion set at the infusion site
•put the pump in RUN mode.
After experiencing an 'E7: ELECTRONIC ERROR' you should always check all settings, including basal rate profile, time and date.
If the fault cannot be cleared, you should follow the alternative therapy plan provided by your treating health professional.
If the error occurs repeatedly, or if you have any other questions or concerns, call Roche on 1800 633 457. Roche Diagnostic Australia will arrange for return and replacement of affected devices.
Therapeutic Goods Administration is the responsible regulator for this recall.