Accu-Chek Spirit Combo insulin pumps

Recall for product correction - potential for high or low blood sugar events

3 October 2014

Consumers and health professionals are advised that Roche Diagnostic Australia, in consultation with the TGA, has initiated a recall for product correction for its Accu-Chek Spirit Combo insulin pumps.

Accu-Chek Spirit Combo insulin pumps deliver continuous doses of insulin to help patients with diabetes maintain safe blood glucose levels.

Accu-Chek Spirit Combo insulin pumpIt has been identified that patients using an Accu-Chek Spirit Combo insulin pump may experience a loss of the date and time settings. This may occur if the capacitor, which provides the voltage to save time and date settings during power interruption (typically during a battery change), fails to function properly.

If the date and time settings are lost, the pump will revert to the default date and time. If the user then fails to reprogram the device to the correct date and time, this could affect when insulin is delivered to the patient and potentially contribute to high or low blood sugar events.

For users with impaired vision, it may be particularly difficult to detect a loss of the date and time settings.

To address this issue, Roche Diagnostic Australia has written to Accu-Chek Spirit Combo insulin pump users, providing instructions on how to correctly change their pump's battery and how to check the date and time settings afterwards.

If this problem is identified after a battery change, Roche Diagnostic Australia will replace the affected pump free of charge.

Please note there have only been a small number of overseas reports of the above issue and no cases have been reported in Australia.

Information for consumers

If you have an Accu-Chek Spirit Combo insulin pump, you should have received a letter from Roche Diagnostic Australia that provides instructions on how to correctly change your pump's battery and how to check the date and time settings afterwards.

If your pump's date and time settings are lost, it could contribute to a high or low blood sugar event. However, please note that this problem has only occurred in a small number of overseas cases.

If you have not received a letter or have any questions or concerns about this issue, contact the Accu-Chek Customer Service Centre on 1800 633 457. Alternatively, you can speak to your diabetes nurse educator or other health professional.

If the above problem is experienced, contact Roche Diagnostic Australia to arrange replacement of the affected pump.

Information for health professionals

If you are treating a patient who uses an Accu-Chek Spirit Combo insulin pump, ensure that they are aware of this issue. Reassure them that this problem has only occurred in a small number of overseas cases.

If they have not received the letter from Roche Diagnostic Australia, or have more questions or concerns about this issue, advise them to contact the Accu-Chek Customer Service Centre on 1800 633 457.

Advise them that, if the date and time settings are lost, Roche Diagnostic Australia will replace the affected pump.

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.