VIDAS BRAHMS PROCALCITONIN 60T

Additional Manufacturer Narrative

FOLLOWING AN INCREASE IN CUSTOMER COMPLAINTS ABOUT ¿SUBSTRATE ERROR¿ ON DIFFERENT VIDAS® REFERENCES TESTED ON ALL VIDAS SYSTEMS, AN INTERNAL INVESTIGATION WAS PERFORMED. INVESTIGATION: DEVICE HISTORY RECORD: THE ANALYSIS OF THE BATCH HISTORY RECORDS OF THE VIDAS LOTS CONCERNED SHOWED NO ANOMALY DURING THE MANUFACTURING, CONTROL, AND PACKAGING PROCESSES. NO NON-CONFORMITY LINKED TO THE CUSTOMER¿S COMPLAINT WAS REGISTERED ON THESE BATCHES. FOLLOWING THE INCREASE OF COMPLAINTS FOR SUBSTRATE ISSUES, A CAPA (CORRECTIVE ACTION PREVENTIVE ACTION) HAS BEEN OPENED TO IDENTIFY THE ACTIONS. TESTS/ANALYSIS PERFORMED: - THE PROBLEM WAS DETECTED ON VIDAS, WHEN THE FLUORESCENCE IS MEASURED (FIRST READ) BEFORE THE BEGINNING OF THE TESTS. IF THERE IS A ¿SUBSTRATE ERROR¿, THE USER HAS AN ERROR MESSAGE ¿ ERRORS/SUBSTRATE ERROR¿ WHICH DISPLAYS ON THE EQUIPMENT MAKING IT IMPOSSIBLE TO RUN TESTS AND GENERATE RESULTS. - THE ¿SUBSTRATE ERROR¿ ISSUE HAS BEEN OBSERVED 5 TO 6 MONTHS AFTER THE DATE OF MANUFACTURING OF THE STRIPS. - DURING THE INVESTIGATION, IT WAS CONFIRMED THAT ONE LOT OF COMMON RAW MATERIAL WAS USED IN ALL SUBSTRATE BATCHES CONTAINED IN VIDAS® IMMUNO-ASSAYS STRIPS WITH A HIGH LEVEL OF COMPLAINTS ABOUT ¿SUBSTRATE ERROR¿ AND THEREFORE THIS BATCH OF RAW MATERIAL WAS IDENTIFIED AS THE MOST PROBABLE COMMON ROOT-CAUSE. - INVESTIGATION PERFORMED AT THE SUPPLIER LEVEL CONFIRMED THAT A LOT OF RAW MATERIAL IN CAUSE IS ATYPICAL AND IS INDEED THE SOURCE OF SUBSTRATE ERRORS ON VIDAS REAGENTS. - AT THE END OF SEPTEMBER 2021, THE MANUFACTURING SITE STOPPED THE PRODUCTION OF THE KITS WITH THE CONCERNED RAW MATERIAL LOT. ROOT CAUSE ANALYSIS AND CONCLUSION: - THE ROOT CAUSES LINKED TO THE SPECIFICATIONS PROCESS AT THE SUPPLIER OF THE RAW MATERIAL HAVE BEEN IDENTIFIED. - CORRECTIVE ACTION WILL BE IMPLEMENTED AT THE SUPPLIER TO ADD SOME SPECIFICATIONS AND CONTROL IN THE MANUFACTURING PROCESS OF THE RAW MATERIAL CONCERNED. - AT BIOMÉRIEUX SITE, AN INCOMING CONTROL WITH STABILITY WILL BE IMPLEMENTED AS A PREVENTIVE ACTION.