VIDAS® B¿R¿A¿H¿M¿S PCT¿

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS PERFORMED FOLLOWING A NOTIFICATION FROM A CUSTOMER FROM ITALY WHO OBTAINED NON-REPRODUCIBLE OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120, EXPIRY DATE: 12-NOV-2025). 1. DEVICE HISTORY RECORD THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING MANUFACTURING, CONTROL AND PACKAGING PROCESSES FOR VIDAS BRAHMS PCT REF 30450 LOT 1010727120. 2. COMPLAINT ANALYSIS AT THE DATE OF INVESTIGATION, NO OTHER COMPLAINTS WERE RECORDED FOR NON-REPRODUCIBLE OVERESTIMATED RESULTS ON VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120). 3. TEST/ANALYSIS PERFORMED 3.1 CONTROL CHARTS ANALYSIS THE COMPLAINTS LABORATORY ANALYZED THE RESULTS OF 4 INTERNAL SAMPLES TARGETED 0.34; 7.80; 40.9 AND 30.7 NG/ML, ON 7 DIFFERENT BATCHES OF VIDAS BRAHMS PCT REF 30450 INCLUDING CUSTOMER¿S LOT 1010727120. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS. CUSTOMER¿S LOT IS IN THE TREND OF THE OTHER LOTS. 3.2 TESTS PERFORMED BY COMPLAINT LABORATORY ON INTERNAL SAMPLES: THE COMPLAINTS LABORATORY TESTED 4 INTERNAL SAMPLES WITH THE RETAIN KIT VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120). ALL SAMPLES RESULTS ARE WITHIN THEIR EXPECTED SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED BEFORE THE RELEASE OF LOT. OTHER TYPE OF SAMPLES: THE COMPLAINTS LABORATORY TESTED IN DUPLICATE 3 FRESH SERA FROM ETABLISSEMENT FRANÇAIS DU SANG (EFS) AND TESTED 4 TIMES INTERNAL CONTROL C1 IN AUTOMATIC PIPETTING WITH THE RETAIN KIT VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120). ALL RESULTS ARE COMPLIANT WITHOUT ANY REPRODUCIBILITY ISSUE. PATIENT SAMPLES: NO PATIENT SAMPLES WERE RETURNED BY THE CUSTOMER FOR FURTHER ANALYSIS. 3.3 LOG / ML2 ANALYSIS IT WAS NOT POSSIBLE TO RETRIEVE THE DATA. 4. ROOT CAUSE ANALYSIS AND CONCLUSION ACCORDING TO ALL INFORMATION ABOVE, NO ANOMALY WAS HIGHLIGHTED WITH THE CONTROL CHART ANALYSIS, THE ANALYSIS OF QUALITY DATA AND THE TESTS PERFORMED ON RETAIN KIT VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120) USING INTERNAL SAMPLES. CUSTOMER¿S ISSUE, IE NON-REPRODUCIBLE OVERESTIMATED RESULTS, WAS NOT REPRODUCED BY COMPLAINTS LABORATORY DURING THE INVESTIGATION CONDUCTED ON INTERNAL SAMPLES, FRESH SAMPLE AND INTERNAL CONTROL C1. ACCORDING TO THE INVESTIGATION OUTPUTS, THE PERFORMANCE OF THE VIDAS BRAHMS PROCALCITONIN (REF. 30450, LOT: 1010727120) IS CONFORM TO THE EXPECTED SPECIFICATIONS.

Description of Event or Problem

ON (B)(6) 2024, A CUSTOMER FROM ITALY NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010727120, EXPIRY DATE: 12-NOV-2025). ON (B)(6) 2024, A CUSTOMER TESTED SAMPLES FROM 2 DIFFERENT PATIENTS WITH VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010727120) AND OBTAINED THE FOLLOWING RESULTS: 1ST PATIENT: - AT 8:45 AM: 26.93 NG/ML. - AT 9:21 AM: < 0.05 NG/ML. - AT 10:01: < 0.05 NG/ML. 2ND PATIENT. - AT 8:45 AM: 23.95 NG/ML. - AT 9:51 AM: 0.32 NG/ML. TO BE NOTED THAT THE CALIBRATION OF THE KIT VIDAS BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010727120) WAS PERFORMED ON 10-OCT-2024 AND WAS VALID. BASED ON THE AVAILABLE INFORMATION AT THE TIME OF THIS ASSESSMENT, IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED OR TREATED INCORRECTLY, AND THERE WAS NO DELAYED RESULT BECAUSE THE CUSTOMER CONSIDERED THAT THE HIGH RESULTS OBTAINED WERE NOT VALID. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED. NOTE: REFERENCE (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE (B)(4).