Accu-Chek field safety notices
Patient safety is our first priority. We are committed to keeping those who use our products, as well as healthcare professionals, informed of issues and solutions related to our products and services.
Specific lots of Accu-Chek Performa test strips potentially showing an increased number of strip errors prior to dosing or biased results
At Roche Diabetes Care we hold our products to the highest standards of quality and are committed to communicating any issues impacting the operation of our products. This is why we would like to inform today about an issue that might occur in certain lots of the Accu-Chek Performa test strips. As part of our ongoing quality monitoring and market surveillance processes, we have identified certain test strip lots that potentially show an increase in strip errors prior to dosing.
Due to the designed fail-safe in the blood glucose meter, the issue can be identified by an error message displayed on the meter upon strip insertion or through the device not recognising the test strip. However, in a very limited number of cases the test strip can produce a biased result i.e. a falsely too high or too low value, which you might not be able to detect easily and which could lead to erroneous therapy adaptations.
What to do next
Check the lot numbers of your test strip supply against the complete list. You can find the lot number on the top flap of the vial packaging as well as on the label of each test strip vial.
Discontinue using strips from the affected lots immediately and please return to the pharmacy or store where you obtained the strips for a replacement pack. If your test strip supply is not from the lots affected, you can continue using these test strips and no additional action is required.
Specific lots that are affected
Please check the lot numbers listed below to see whether your products are included in this field safety notice.
ACCU-CHEK PERFORMA STRIPS (10s)
Accu-Chek Performa Nano mmol Kit.
(Please note that the FSN only applies to the pack of Performa 10 test strips contained within the kit)
Frequently asked questions
Has this issue been corrected?
We have thoroughly investigated this issue to identify the root cause of this potential error and have already started to implement the appropriate corrective measures.
Are other Accu-Chek products affected?
Please be assured that this issue only affects specific lots of the Accu-Chek Aviva and Accu-Chek Performa test strips in the UK. Other Accu-Chek blood glucose test strips available in your market are not impacted by this issue.
Who has been advised of this issue?
The MHRA, healthcare professionals, hospitals, distributors and retailers have been informed about this field action.
How does this Field Safety Notice (FSN) affect the Accu-Chek Performa meters?
This FSN does not affect the meter at all, it only relates to specific lots of the test strips. The meter can be used as normal and does not need to be replaced.
Who can I contact if I have further questions or concerns?
In the first instance we encourage you to return any affected products to the pharmacy or store where you obtained the strips for a replacement pack. If you need any additional advice on the operation of your Accu-Chek blood glucose meter and test strips or have any further questions or concerns please contact the Accu-Chek Customer Careline on 0800 701 000 (UK) or 1 800 709 600 (ROI). If you are a pump user please contact the Accu-Chek Pump Careline on 0800 731 2291 (UK) or 1 800 882 351 (ROI).