Middle East, October 28,2019

Important information on Accu-Chek® Aviva / Accu-Chek^® Performa blood glucose meters potentially having power-related issues

Description of the Situation

An issue was discovered during the manufacturing process of the meter where an internal component of the meter might have been damaged.

• In a small percentage of meters, this damage could cause an accelerated depletion of the meter’s battery. 

Affected devices

The following products are affected:

Clinical Significance

The damage of the internal component of the meter may result in a meter unavailability for the user, and failure to test could cause a delay in therapy decisions potentially leading to a serious medical condition.  

Actions taken by Roche Diabetes Care

Roche Diabetes Care implemented corrective actions to eliminate the root cause for the damage of the internal component.

Actions to be taken by the user of the Accu-Chek® Aviva / Accu-Chek® Performa blood glucose meters

• In order to troubleshoot any power related issue, refer to the instructions in the user’s manual on how to appropriately handle any errors that may occur.
• If the instructions provided in the user’s manual are not solving the issue, please contact our Roche Diabetes Care Customer Care line to obtain further support:

*For all other countries please visit our support page for local contacts

• Additional user information on the handling of Accu-Chek^® Aviva / Accu-Chek^® Performa blood glucose meters are provided on the rochediabetescareme.com webpage (FAQs)

Please find below the following warning and important notices regarding potential power issues.

• Notice:

If you use a meter with a serial number (where "XXX" is the first 3 digits of the serial number) in the defined serial number range, you may have a meter potentially impacted by the damaged component.

• Accu-Chek^® Aviva: between XXX05000001 andXXX06335297 OR
• Accu-Chek^® Aviva: between XXX20000000 and XXX23284925
• Accu-Chek^® Performa: between XXX20000000 and XXX25525056

• If you believe you have a meter in the impacted serial number range, please consider the following warnings:

1. Always have a spare set of batteries. 
2. Have a back-up testing method available.

This notification is being made with the knowledge of the Food and Drug Administration (FDA).You may also report adverse events or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Events Reporting Program online at www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail),

or call the FDA 1-800-FDA-1088.

Roche Diabetes Care Middle East FZCO

ACCU-CHEK AVIVA is a trademark of Roche.

ACCU-CHEK PERFORMA is a trademark of Roche.