Medical device manufacturer, BioMerieux, has issued a medical device safety alert concerning its VIDAS 3 [Software versions 1.2 and higher, Reference Number: 412590].
Following customers complaints, the manufacturer's investigations have been initiated on potentially false results obtained on VIDAS 3 with an expired calibration. The calibrations of assays were valid in the calibration menu whereas in fact the calibrations were expired and no alarm displayed to warn the users about the expiration date of the calibrations. Software computes results of analysis for assays with expired calibrations. The anomaly is due to an incorrect update of the calibration status by the software.
According to the manufacturer, the issue is due to a software anomaly regarding the software versions 1.2 and higher. The issue occurred only VIDAS 3 instrument (with software versions 1.2.0 and higher). VIDAS Legacy and mini-VIDAS instruments are not affected by this issue.
The issue occurs if the following conditions coexist at customer site:
- VIDAS 3 installed with software versions 1.2.0 and higher
- Archiving mode is configured as "when results are reported"
- One calibration in "TO DO" status in the calibration menu
- Expiration of the lot(s) concerned by the "TO DO" calibration
Affected users are required to take the following actions:
- To check if users might be concerned by the incorrect software configuration, follow the instructions mentioned in the Field Safety Notice: Check the VIDAS 3 software version, follow the different steps listed.
- If the VIDAS 3 software versions is 1.1.4, the users are not concerned by the issue. If the VIDAS 3 software version is between 1.2.0 and 1.3.1, check the archiving mode: To do so follow the different steps listed in the FSN.
- If the archiving mode is "Automatic at a given time", the users are not concerned by the issue. If the archiving mode is "Automatic when results are reported", the users might be concerned by the issue only if the four conditions listed above are verified at the same time. To solve the problem, change manually the archiving mode "Automatic when results are reported" and select the archiving mode "Automatic at a given time". Save the modification and reboot the computer.
- Contact local customer service if the users have the incorrect software configuration and if have a doubt regarding the results.
- Discuss any concerns users may have regarding previously reported patient results obtained with Laboratory Medical Director to determine the appropriate course of action. Results should be reviewed and interpreted in the context of the overall clinical picture.
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 23 October 2019