VIDAS® B·R·A·H·M·S PCT ¿

Description of Event or Problem

ON 28-NOV-2024, A CUSTOMER FROM CHINA NOTIFIED BIOMÉRIEUX OF OBTAINING NON-REPRODUCIBLE OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS® BRAHMS PROCALCITONIN (REF. (B)(4), LOT: 1010555200, EXPIRY DATE: (B)(6) 2025). ON THE MORNING OF NOVEMBER 26, THE VIDAS® BRAHMS PROCALCITONIN RESULT WAS 4.48 AND THE C-REACTIVE PROTEIN RESULT WAS LESS THAN 3.31 AT THE FIRST TIME. BECAUSE THE PATIENT WAS CLINICALLY DIAGNOSED WITH URINARY TRACT INFECTION, THE CUSTOMER CONFIRMED THE BACTERIAL INFECTION AGAIN TO CONFIRM THE VIDAS® BRAHMS PROCALCITONIN POSITIVE RESULT. A RETEST WAS DONE AT TWO DIFFERENT LOCATIONS AND THE RESULTS WERE : 0.05, WHICH WAS NEGATIVE. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE ISSUE LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH NOR DELAY IN RENDERING THE RESULTS. 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).

Additional Manufacturer Narrative

AN INTERNAL INVESTIGATION WAS COMPLETED FOLLOWING NOTIFICATION FROM A CUSTOMER IN CHINA ABOUT OBTAINING NON-REPRODUCIBLE OVERESTIMATED RESULTS WHEN TESTING PATIENT SAMPLES WITH VIDAS® BRAHMS PROCALCITONIN (REF. 30450-86, LOT: 1010555200, EXPIRY DATE: 11-AUG-2025). NO SAMPLE NOR ANY KIT WAS RECEIVED FROM CUSTOMER FOR THE INVESTIGATION. INVESTIGATION OUTCOMES: THE REVIEW DID NOT HIGHLIGHT ANY ISSUE DURING THE MANUFACTURING PROCESS OF VIDAS® B.R.A.H.M.S PCT REF.30450-86 LOT 1010555200. COMPLAINT ANALYSIS: THE COMPLAINT ANALYSIS DID NOT REVEAL THIS ISSUE AS A SYSTEMIC QUALITY ISSUE. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY. CONTROL CHART ANALYSIS: THIS ANALYSIS WAS CARRIED OUT: ON FOUR (4) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 0.15 / 3.03 / 3.92 AND 7.80 NG/ML. ON SEVEN (7) LOTS OF VIDAS® B.R.A.H.M.S PCT REF.30450-86 INCLUDING THE LOT 1010555200 MENTIONED BY THE CUSTOMER. THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS ARE WITHIN SPECIFICATIONS, AND THE LOT MENTIONED ABOVE IS IN THE TREND COMPARED TO THE OTHER LOTS. TESTS ON INTERNAL SAMPLE: THE COMPLAINTS LABORATORY TESTED THREE (3) INTERNAL SAMPLES WITH THE FOLLOWING TARGETS 0.34, 3.03 AND 7.80 NG/ML ON THE RETAIN KIT OF VIDAS® B.R.A.H.M.S PCT REF.30450-86 LOT 1010555200. THE RESULTS COMPLIED TO THE SPECIFICATIONS AND WERE CLOSE TO THE RESPECTIVE TARGET OF EACH SAMPLE WITHOUT ANY SIGNIFICANT DIFFERENCE COMPARED TO THE ONES OBSERVED BEFORE THE BATCH RELEASE. BIOMÉRIEUX DID NOT OBSERVE ANY EVOLUTION OVER TIME OF THEIR ACTIVITY. REPEATABILITY TESTING: AN INTERNAL SAMPLE WITH A TARGET AT 7.80 NG/ML (CLOSE TO THE INITIAL RESULTS OBSERVED BY THE CUSTOMER) WAS TESTED IN DUPLICATE AND THE RESULTS WERE COMPARED TO ONE OBTAINED DURING A PREVIOUS RUN. THE RESULTS WERE BETWEEN 7.07 AND 7.39 NG/ML WITH A CV AT 2.3%, WHICH IS IN ACCORDANCE WITH SPECIFICATIONS. SIX (6) SAMPLES FROM A FRENCH BLOOD DONOR CENTER WERE TESTED DURING TWO (2) RUNS, AND THE RESULTS WERE COMPARED BETWEEN THE TWO (2) RUNS : ALL THE RESULTS WERE < 0.05 NG/ML FOR BOTH RUNS. BIOMÉRIEUX DID NOT OBSERVE ANY REPRODUCIBILITY ISSUE NOR OVERESTIMATED RESULTS WITH THESE SAMPLES. CONCLUSION: BIOMÉRIEUX DID NOT HIGHLIGHT ANY ISSUE WHEN ANALYZING ALL THE DATA. NEITHER THE REPRODUCIBILITY ISSUE NOR THE OVERESTIMATED RESULTS WERE REPRODUCED WHEN TESTING INTERNAL SAMPLES AND SAMPLES FROM BLOOD DONOR. BIOMÉRIEUX DID NOT IDENTIFY THE OBVIOUS ROOT CAUSE. WITHOUT MATERIAL FROM CUSTOMER, IT WAS NOT POSSIBLE TO PURSUE FURTHER INVESTIGATION. ONE HYPOTHESIS WOULD BE THE PRESENCE OF REMAINING CELL FRAGMENTS OR MICRO CLOTS OF FIBRIN THAT HAVE INTERFERED WITH THIS VIDAS ASSAY. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF VIDAS® B.R.A.H.M.S PCT REF.30450-86 LOT 1010555200.