VIDAS® CMV IGG

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 1009747150, EXPIRY DATE 06-OCT-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 # 1009747150 (THIS LOT): 177 UA/ML AND 309 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.(B)(4) 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.(B)(4) 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.(B)(4) 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.(B)(4) LOTS 1009465780,1009662190 AND 1009747150.

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 06-MAR-2023, A CUSTOMER FROM PORTUGAL REPORTED TO BIOMERIEUX THAT THEY OBSERVED NONREPRODUCIBLE UNDERESTIMATED RESULTS WITH VIDAS® CMV IGG 60 TESTS (REF. 30204, BATCH 1009747150, EXPIRY DATE 06-OCT-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 # 1009747150 (THIS LOT): 177 UA/ML AND 309 UA/ML. FOR THE SAME SAMPLE, THE CUSTOMER OBTAINED VARIABLE RESULTS FOR CMV IGG (CMVG) USING A SECOND LOT # 1009465780 (CN-469612): 235 UA/ML, >400 UA/ML, 232 UA/ML (SPECIFIC LOT FOR THIS RESULT NOT SPECIFIED), 799 UA/ML, 382 UA/ML. FOR THE SAME SAMPLE, THE CUSTOMER OBTAINED VARIABLE RESULTS FOR CMV IGG (CMVG) USING A THIRD LOT # 1009662190 (CN-476116): 167 UA/ML AND 167 UA/ML. (B)(6) 2023 AT 11:46 INSTRUMENT VN05719 / UNDILUTED SAMPLE. VIDAS CMVG : 177 UA/ML (5912 RFV) MANUAL PIPETTING/ POSITION B2 CALIBRATION FROM (B)(6) 2023. (B)(6) 2023 AT 11:46 INSTRUMENT VN05719 / UNDILUTED SAMPLE. VIDAS CMV AVIDITY (CMVA) - (CMVG REF. AT 6433 RFV AND 309 UA/ML) MANUAL PIPETTING/ POSITION D1 FOR REF AND D2 FOR TEST. ==> AVIDITY INDEX = 0.93. CALIBRATION FROM (B)(6) 2023. 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 30204 IS NOT REGISTERED IN THE UNITED STATES. THE U.S. SIMILAR DEVICE IS PRODUCT REFERENCE 30204-01. A BIOMÉRIEUX INTERNAL INVESTIGATION HAS BEEN INITIATED.