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Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, is notifying users of Accu-Chek Spirit Combo insulin pumps with serial numbers between 10171897 and 10281629 of a potential fault that may prevent treatment.
Accu-Chek Spirit Combo insulin pumps deliver continuous doses of insulin to diabetic patients.
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.
Roche Diagnostic Australia will recall affected Accu-Chek Spirit Combo insulin pumps that repeatedly display the 'E7: ELECTRONIC ERROR' error message and provide replacements.
Roche Diagnostic Australia advises that the issue affects less than 0.5% of pumps and does not affect new pumps with product serial numbers from 10281630 onwards.
Information for consumers
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.
Information for health professionals
If you are treating patients who use Accu-Chek Spirit Combo insulin pumps, be aware of this issue. Reassure them that this fault only poses an ongoing problem in a small percentage of devices.
Advise your patients to follow the instructions in the operator's manual if they experience the 'E7: ELECTRONIC ERROR' message and ensure that they are familiar with their alternative treatment plan in the event of this fault preventing treatment.
If your patients experience this error repeatedly, or have any other questions or concerns, they should call Roche on 1800 633 457. Roche Diagnostic Australia will arrange for return and replacement of affected devices.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.