PRA number
2014/14140
Published date
Product description
Accu-Chek Spirit Combo insulin pumps deliver continuous doses of insulin to diabetic patient.
Reasons the product is recalled
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.
The hazards to consumers
Potential for delay to treatment in rare cases.
What consumers should 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.
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.
Supplier
Roche Diagnostics Australia Pty Limited
Where the product was sold
Australian Capital Territory
New South Wales
Queensland
South Australia
Tasmania
Victoria
Western Australia
Responsible regulator
Therapeutic Goods Administration is the responsible regulator for this recall.