VIDAS® CMV IGG

Description of Event or Problem

INTENDED USE: VIDAS CMV IGG IS AN AUTOMATED QUANTITATIVE ENZYME IMMUNOASSAY FOR USE ON THE VIDAS FAMILY INSTRUMENTS FOR THE QUANTITATIVE MEASUREMENT, OF ANTI-CYTOMEGALOVIRUS IGG (CMVG) IN HUMAN SERUM, USING THE TECHNIQUE ELFA (ENZYME LINKED FLUORESCENT ASSAY). RESULTS INTERPRETATION: VALUE (AU/ML) INTERPRETATION, 4 NEGATIVE, 4 AND 6 EQUIVOCAL, 6 POSITIVE. ISSUE DESCRIPTION: ON (B)(6) 2023, A CUSTOMER FROM PORTUGAL REPORTED TO BIOMERIEUX THAT THEY OBSERVED NONREPRODUCIBLE UNDERESTIMATED RESULTS WITH VIDAS® CMV IGG 60 TESTS (REF: (B)(4), BATCH: 1009465780, EXPIRY DATE 11-MAY-2023) WITH PATIENT SAMPLES ON A VIDAS® 3 INSTRUMENT (VN05719). FOR THE SAME SAMPLE, THE CUSTOMER OBTAINED VARIABLE RESULTS FOR CMV IGG (CMVG) USING LOT#: 1009465780: 235 UA/ML, 400 UA/ML, 232 UA/ML (SPECIFIC LOT FOR THIS RESULT NOT SPECIFIED), 799 UA/ML, 382 UA/ML. SUMMARY OF RESULTS FOR SAMPLE 7852. 13FEB2023 AT 12:08 INSTRUMENT VN05719 / UNDILUTED SAMPLE. ------------------------------------------------------------------------- VIDAS CMVG: 235 UA/ML (6526 RFV) AUTOMATIC PIPETTING/ POSITION A2 CALIBRATION FROM 07FEB2023. 14FEB2023 AT 12:08 INSTRUMENT VN05719 / UNDILUTED SAMPLE. ------------------------------------------------------------------------ VIDAS CMV AVIDITY (CMVA) (CMVG REF. AT 7297 RFV AND 400 UA/ML) MANUAL PIPETTING/ POSITION A2 FOR REF AND A3 FOR TEST. INVALID RESULT / NO AVIDITY INDEX: CALIBRATION FROM 07FEB2023. 14FEB2023 VERIFICATION OF CMVG RESULTS ON INSTRUMENT VN05719. VIDAS CMVG: 232 UA/ML (NO INFORMATION ABOUT POSITION). 16FEB2023 AT 13:32 INSTRUMENT VN05719 / SAMPLE DILUTED 1:3. VIDAS CMVA: INVALID RESULT (CMVG REF. AT 6652 RFV AND 799 UA/ML) MANUAL PIPETTING/ POSITION A2 FOR REF AND A3 FOR TEST. AVIDITY INDEX = 0.86 CALIBRATION FROM 07FEB2023. 17FEB2023 AT 13:36 ON A DIFFERENT VIDAS® 3 INSTRUMENT (VN06008) / UNDILUTED SAMPLE. VIDAS CMVA: (CMVG REF. AT 7238 RFV AND 382 UA/ML) MANUAL PIPETTING/ POSITION A1 FOR REF AND A2 FOR TEST. INVALID RESULT / NO AVIDITY INDEX. CALIBRATION FROM 17FEB2023. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO THE PATIENT'S STATE OF HEALTH. NOTE: REFERENCE: (B)(4) IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE: 30204-01. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.

Additional Manufacturer Narrative

THIS REPORT WAS INITIALLY SUBMITTED FOLLOWING NOTIFICATION FROM A CUSTOMER IN PORTUGAL REGARDING NONREPRODUCIBLE UNDERESTIMATED RESULTS WITH VIDAS® CMV IGG 60 TESTS (REF. 30204, BATCH 1009465780, EXPIRY DATE 11-MAY-2023) WITH PATIENT SAMPLES ON A VIDAS® 3 INSTRUMENT (VN05719) . FOR THE SAME SAMPLE, THE CUSTOMER OBTAINED VARIABLE RESULTS FOR CMV IGG (CMVG) USING LOT # 1009465780: 235 UA/ML, >400 UA/ML, 232 UA/ML (SPECIFIC LOT FOR THIS RESULT NOT SPECIFIED), 799 UA/ML, 382 UA/ML. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN COMPLETED WITH THE FOLLOWING RESULTS: CUSTOMER MATERIAL: NO PATIENT SAMPLES WERE AVAILABLE FOR TESTING PURPOSES. INVESTIGATION OUTCOMES: COMPLAINT ANALYSIS: UNTIL NOW, ONLY THE THREE (3) COMPLAINTS FROM THIS CUSTOMER AND THEIR THREE (3) LOTS HAVE BEEN RECORDED FOR A REPRODUCIBILITY ISSUE FOR VIDAS CMV IGG.: LOT 1009465780, MEDWATCH 8020790-2023-00014; LOT 1009662190, MEDWATCH 8020790-2023-00015; LOT 1009747150, MEDWATCH 8020790-2023-00016. QUALITY CONTROL RECORDS: THERE IS NEITHER CAPA NOR NON-CONFORMITY LINKED TO THIS ISSUE ON THIS VIDAS ASSAY. ANALYSIS AND TESTS CONDUCTED BY COMPLAINTS LABORATORY: **CONTROL CHART ANALYSIS** THIS ANALYSIS WAS CARRIED OUT: ON FOUR (4) INTERNAL SAMPLES WITH A TARGET DISTRIBUTED BETWEEN 107 AND 230 UA/ML. ON SEVEN (7) BATCHES OF VIDAS CMV IGG REF.30205 INCLUDING THE LOTS MENTIONED BY THE CUSTOMER (1009465780, 1009662190, AND 1009747150). THE ANALYSIS OF THE CONTROL CHARTS SHOWED THAT ALL RESULTS WERE WITHIN SPECIFICATIONS AND THREE (3) LOTS LISTED ABOVE ARE IN THE TREND COMPARED TO THE OTHER LOTS. **TEST ON INTERNAL SAMPLES** THE COMPLAINTS LABORATORY TESTED: THREE (3) INTERNAL SAMPLES WITH A TARGET AT 126, 170 AND 230 UA/ML ON THE LOTS MENTIONED BY THE CUSTOMER (1009465780,1009662190 AND 1009747150). THE RESULTS COMPLIED WITH THE SPECIFICATIONS AND THE RESULTS WERE NOT SIGNIFICANTLY DIFFERENT COMPARED TO THOSE OBSERVED BEFORE THE BATCH RELEASE. NO EVOLUTION OVER TIME OF THESE SAMPLES ACTIVITY WAS OBSERVED. ***REPRODUCIBILITY TESTING ON A SAMPLE FROM BLOOD DONOR** THE COMPLAINTS LABORATORY TESTED 4 (FOUR) TIMES A BLOOD DONOR SAMPLE ON EACH LOT MENTIONED BY THE CUSTOMER USING DIFFERENT RUNS OF ANALYSIS (BETWEEN-RUN REPEATABILITY WITH A TOTAL OF 12 REPETITIONS). THE SAMPLE GAVE A RESULT BETWEEN 53 AND 69 UA/ML WITH A MEAN OF 60 UA/ML AND A CV OF 9%. THE WITHIN-LOT VARIABILITY IS BETWEEN 4.54 AND 6.80% AND IT IS IN ACCORDANCE WITH THE SPECIFICATION CV OF 7%. THE BETWEEN-LOT VARIABILITY OF 9% IS ALSO IN ACCORDANCE WITH THE SPECIFICATION CV. ***REPRODUCIBILITY TESTING ON SAMPLES FROM MASTER CURVE** THE COMPLAINTS LABORATORY TESTED TWO (2) SAMPLES EIGHT (8) TIMES WITH HIGH CONCENTRATIONS COMING FROM THE MASTER CURVE DETERMINATION. THE SAMPLES F AND G (RESPECTIVE TARGET ABOUT 205 AND 380 UA/ML), TESTED ON THE THREE (3) LOTS MENTIONED BY THE CUSTOMER, GAVE RESULTS COMPLYING WITH EXPECTATIONS, WITH ONE RESULT ABOVE 400 UA/ML OUT OF 24 DATA. THE VARIABILITY UNTIL 14.5% OBSERVED ON THE RESULTS IS SIMILAR TO THE ONE OBSERVED DURING THE CONTROL OF THE LOT. ***CMV AVIDITY TESTING ON SAMPLES F AND G FROM MASTER CURVE** SAMPLES F AND G WERE ASSAYED FOR AVIDITY TESTING USING VIDAS CMV IGG LOT 1009465780. THE SAMPLE G GAVE A RESULT > 400 UA/ML WITH THE REFERENCE STRIP WHICH WILL LEAD TO AN INVALID RESULT ON VIDAS 3 (WHILE IN PREVIOUS TESTING, IT GAVE 23 TIMES RESULTS BELOW 400 UA/ML). THIS SAMPLE GAVE A RESULT OF 504 UA/ML WHEN TESTING DILUTED 1:4 IN SALINE SERUM. THE AVIDITY INDEX WAS 0.90 WITH THE DILUTED SAMPLE. THE COMPLAINTS LABORATORY REPRODUCED THE VARIABILITY OF RESULTS OBSERVED BY THE CUSTOMER FOR SAMPLE WITH HIGH CONCENTRATIONS OF IGG ANTIBODIES. ***EXTRACT FROM VIDAS CMV IGG PACKAGE INSERT*** IT IS MENTIONED IN THE PACKAGE INSERT OF VIDAS CMV IGG REF.30204 AT SECTION RESULTS AND INTERPRETATION ¿SAMPLES WITH ANTI-CMV IGG CONCENTRATIONS > 400 AU/ML SHOULD BE RE-ASSAYED AFTER DILUTION BY 1/4 IN SALINE SOLUTION. IF THE DILUTION FACTOR HAS NOT BEEN ENTERED WHEN THE WORK LIST WAS CREATED, MULTIPLY THE RESULT BY THE DILUTION FACTOR TO OBTAIN THE SAMPLE CONCENTRATION. FOR SEROLOGICAL MONITORING, TO OBTAIN AN ACCURATE SERUM TITER, DILUTE THE SAMPLES WITH CONCENTRATIONS > 150 AU/ML IN ORDER TO OBTAIN A RESULT RANGING BETWEEN 50-150 AU/ML¿. CONCLUSION: THE COMPLAINTS LABORATORY REPRODUCED THE VARIABILITY OF RESULTS OBSERVED BY THE CUSTOMER USING VIDAS CMV IGG ASSAY BUT ONLY WITH A SAMPLE WITH HIGH CONCENTRATIONS OF IGG ANTIBODIES. IT IS IN ACCORDANCE WITH THE QUALITY CONTROL OUTCOMES. THE VARIABILITY OBSERVED FOR LOWER IGG CONCENTRATION WAS LOWER (< 9%). THIS VARIABILITY CAN LEAD TO INVALID RESULT WITH VIDAS CMV AVIDITY REF.413557 IF THE RESULT FOR THE REFERENCE STRIP IS ABOVE 400 UA/ML WITH THE FOLLOWING MESSAGE ERROR ¿3012XSFT1 REFERENCE RESULT EXCEEDS THE MAXIMUM LIMIT, IMPOSSIBLE TO CALCULATE THE INDEX¿. AS MENTIONED IN THE PACKAGE INSERT OF VIDAS CMV IGG, IT IS IMPORTANT FOR HAVING AN ACCURATE IGG ANTI CMV RESULT TO DILUTE SAMPLES WITH CONCENTRATIONS > 150 UA/ML, IT WILL AVOID TO HAVE A MESSAGE ERROR WHEN TESTING THE SAMPLE ON VIDAS CMV IGG AVIDITY ASSAY. ACCORDING TO THE DATA MENTIONED ABOVE, THERE IS NO RECONSIDERATION OF THE PERFORMANCES OF VIDAS CMV IGG REF.30204 LOTS 1009465780,1009662190 AND 1009747150.