Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Accu-Chek Performa blood glucose meters [Serial Numbers between 68920000000 and 68925525056].
The manufacturer has identified that Accu-Chek Performa blood glucose meters may potentially have unexpected short battery life or not power on. 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. However, in the worst case, this 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. In order to troubleshoot any power related issue, affected users should refer to the instructions in the user's manual on how to appropriately handle any errors that may occur. Additional user information on the handling of Accu-Chek Performa blood glucose meters are provided on the manufacturer webpage.
If affected users have a meter in the impacted serial number range, they should consider the following warnings:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 8 November 2019