Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Accu-Chek Aviva blood glucose meters [Serial numbers between XXX05000001 and XXX06335297 or Serial numbers between XXX20000000 and XXX23284925].

As part of the manufacturer's ongoing quality monitoring and market surveillance processes, it has identified that Accu-Chek Aviva blood glucose meters may potentially have unexpected short battery life or not power on.

According to the manufacturer, 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, the damage could cause an accelerated depletion of the meter's battery. However, in the worst case, the issue may result in meter unavailability for the user, and failure to test could cause a delay in therapy decisions, potentially leading to a serious medical condition.

The manufacturer has implemented corrective actions to eliminate the root cause for the damage of the internal component.

The affected users are advised to take the following actions:

• 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, they should contacted the manufacturer's Diabetes Care Customer Careline to obtain further support;
• Always have a spare set of batteries;
• Have a back-up testing method available.

According to the local supplier, the affected products are not distributed in Hong Kong.

If you are in possession of the affected product, please contact your supplier for necessary actions.

Posted on 3 December 2019