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URGENT NOTIFICATION

According to Health Canada Medical Device Regulations, we are required to provide the following information to all potential users.

Additionally, in order to comply with the regulations, an answer to this Urgent Notification is required by November 8th, 2019.

 

  I attest that I have read the document and understand the issue at hand.

 

At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting our products. This is why we would like to inform you that as part of our ongoing quality monitoring and market surveillance processes, we have identified that, in some cases, Accu-Chek® Guide blood glucose meters may encounter the following issues:

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

The error rate for meters returned from complaints was estimated as no worse than 1% of the blood glucose tests performed.

Power issues such as those listed above may result in the meter being temporarily unavailable for testing. Failure to test could cause a delay in therapy decisions and may potentially lead to a serious medical condition. As patient safety is our primary concern, we want to communicate to users the below mentioned notices to ensure optimal battery life performance.

Rest assured, we have thoroughly investigated this issue to identify the root cause and have already started to implement the appropriate corrective measures. This includes design improvements to make the meters more robust against battery performance issues.

We sincerely apologize for any inconvenience this may cause and hope that the enhanced handling information provided with this communication supports you while using your Accu-Chek Guide blood glucose meter.

Impacted products:

Accu-Chek Guide blood glucose meters with a serial number below XXX11000001 (where "XXX" is the first 3 digits of the serial number). The serial number can be found on the back of the meter, as indicated by the yellow rectangle in the photo below.

 

Please find below important notices to ensure optimal battery life performance and recommendations on how to handle power issues:

If the meter is powered on and displaying 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 the meter back on.

3. If the problem persists, perform a meter reset by doing the following:

        - Remove the batteries,
        - Press and hold the OK button for at least 2 seconds,
        - Reinsert the batteries.
4. If the problem still occurs after performing a meter reset, then replace the batteries with new ones according to the instructions in the user manual. Use high quality batteries in the meter.
5. If replacing the batteries does not correct the situation, please contact our
Accu-Chek Customer Care line at 1-800-363-7949 to obtain further support

If the 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 OK button for at least 2 seconds,
        - Reinsert the batteries.
3. If the problem still occurs after performing a meter reset, then replace the batteries with new ones according to the instructions in the user manual. Use high quality batteries in the meter.
4. If replacing the batteries does not correct the situation, please contact our ​Accu-Chek Customer Care line at 1-800-363-7949 to obtain further support

Also, always have a spare set of batteries and note that battery life may vary due to factors such as temperature and battery manufacturer.  Have a back-up testing method available.

Should you need more information, please do not hesitate to contact Accu-Chek Customer Care line at 1-800-363-7949 or also by e-mail at laval.info_line@roche.com.  

Roche Diabetes Care thanks you for your continued support.

 

 I attest that I have read the document and understand the issue at hand.