Accu-Chek Guide and Accu-Chek Performa blood glucose meters

Consumers and health professionals are advised that Roche Diabetes Care Australia, in consultation with the TGA, is undertaking a product defect correction for Accu-Chek Guide and Accu-Chek Performa blood glucose meters.

Accu-Chek Guide and Accu-Chek Performa blood glucose meters are used by people with diabetes to monitor their blood glucose (known as blood sugar) levels. These meters are supplied individually and also, in the case of Accu-Chek Guide, in a meter kit.

It has been identified that Accu-Chek Guide blood glucose meters with serial numbers lower than 92911000001 and Accu-Chek Performa blood glucose meters with serial numbers between 68920000000 and 68925525056 (see image for serial number placement on the back of the meter) may:

• Display E-9 Errors (indicating that the batteries need to be replaced)
• Unexpectedly display the low battery icon
• Have short battery life
• Not power on.

If any of the above issues occur, it can lead to temporary meter unavailability that could cause a delay in therapy decisions, which in turn could lead to a serious medical issue.

For information about what to do if one or more of these battery issues occur, see 'Information for consumers' below.

Roche Diabetes Care Australia is investigating these issues to identify the root cause and is already implementing corrective measures, such as design improvements, to address them in new models.

Information for consumers

Roche Diabetes Care Australia has written to consumers who use Accu-Chek Guide or Accu-Chek Performa blood glucose meters to provide further information about this issue, including general precautions and instructions on what to do if you experience the battery issues described above.

If you or someone you provide care uses a Accu-Chek Guide or Accu-Chek Performa blood glucose meter, as a precaution:

• Always have a spare set of high quality batteries
• Be mindful that battery life may be affected by factors such as temperature and battery manufacturer
• Have a back-up testing method available.

If your meter is powered on and displays an E-9 error or low battery icon:

1. Move the meter to a more moderate environment to ensure optimal battery life performance
2. Turn the meter off, then turn it back on
3. If the problem persists, perform a meter reset by doing the following:
   • Remove the batteries
   • Press and hold the Power/Set/OK button for at least 2 seconds
   • Reinsert the batteries
4. If the problem still occurs after performing a meter reset, replace the batteries with new, high quality batteries according to the instructions in the Accu-Chek Guide or Accu-Chek Performa User's Manual
5. If replacing the batteries does not correct the situation, please call the Roche Diabetes Care Enquiry line on 1800 800 535 to obtain further support.

If your meter will not power on or has short battery life:

1. Move the meter to a more moderate environment to ensure optimal battery life performance
2. Perform a meter reset by doing the following:
   • Remove the batteries
   • Press and hold the Power/Set/OK button for at least 2 seconds
   • Reinsert the batteries
3. If the problem still occurs after performing a meter reset, replace the batteries with new, high quality batteries according to the instructions in the Accu-Chek Guide or Accu-Chek Performa User's Manual
4. If replacing the batteries does not correct the situation, please call the Roche Diabetes Care Enquiry line on 1800 800 535 to obtain further support.

If you have any questions or concerns about this issue, speak to your diabetes nurse educator or other health professional.

Information for health professionals

If you are treating someone who uses an Accu-Chek Guide or Accu-Chek Performa blood glucose meter, please be aware of this issue and advise your patients accordingly.

If you or your patients have any questions, visit https://www.accu-chekbattery.com.au/info or call the Roche Diabetes Care Enquiry line on 1800 800 535.

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.