Medical device manufacturer, Roche, has issued a medical device safety alert concerning its Accu-Chek Guide blood glucose meters [Serial numbers below XXX11000001, where "XXX" is the first 3 digits of the serial number].
The manufacturer has identified that the affected products may potentially:
According to the manufacturer, power issues such as those listed may result in a temporary meter unavailability for the user. Failure to test could cause a delay in therapy decisions and may potentially lead to a serious medical condition.
The manufacturer has thoroughly investigated the issue to identify the root cause and has already started to implement the appropriate corrective measures, including design improvements. It also provides the healthcare professionals and their patients with specific instructions on how to handle power issues of the affected products.
The affected users are advised to follow below warnings to ensure optimal battery life performance:
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 22 October 2019