BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 6845876 · Received September 6, 2017

    Report

    Report Number
    3002769706-2017-00272
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Report Date
    July 16, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BIOMÉRIEUX WAS ABLE TO PERFORM ADDITIONAL TESTING WITH BIORAD VIROTROL INTERNAL QUALITY CONTROL (IQC) SAMPLES IN ASSOCIATION WITH VIDAS® CMV IGM (LOT 1005712890). VIROTROL TORCH IQC LOTS 128620 AND 128630 WERE TESTED ON DIFFERENT BATCHES OF VIDAS CMVM (1005685430, 1005712890, 1005756380, AND 1005824730). A SIMILAR TV DECREASE WITH BOTH IQC (VIROTROL) LOTS GAVE A POSITIVE OR AN EQUIVOCAL INTERPRETATION DEPENDING ON THE BATCH TESTED. RESULTS OBSERVED IN THE CUSTOMERS LABORATORIES WERE REPRODUCED. RESULTS: VIROTROL TORCH M LOT 128620 : FROM INDEX 1.61 TO TV 1.09. VIROTROL TORCH M LOT 128630 : FROM INDEX 1.24 TO TV 0.78 . TWO POSITIVE SAMPLES WITH A TARGET CLOSE THE CUT OFF WERE TESTED ON THE SAME BATCHES MENTIONED ABOVE. THEY GAVE VALUES CLOSE TO THEIR EXPECTED TARGET AND GAVE A POSITIVE INTERPRETATION. THE DECREASE AND INTERPRETATION CHANGES WITH NATURAL SAMPLES FROM PATIENTS WERE NOT REPRODUCED. FURTHER INVESTIGATION INTO THE DETAILS OF THE MANUFACTURING PROCESS AND A CAPA, IDENTIFIED THE ROOT CAUSE AS AN ISSUE WITH THE EQUIPMENT USED FOR THE SONICATION OF THE AG (AGGRAVATING FACTOR) USED AT THE MANUFACTURING SITE. A DECREASE OF EFFICIENCY WAS OBSERVED DURING THE FRAGMENTATION OF THE ANTIGEN. A NEW SONICATOR WAS PUT IN PLACE, AND CURRENT LOTS PRODUCED ARE FOLLOWED UP USING AN ADDITIONAL CONTROL FOR SIX MONTHS IN ORDER TO CHECK THE EFFICIENCY OF THE IMPROVEMENT.

    Additional Manufacturer Narrative · 1

    A BIOMÉRIEUX INTERNAL INVESTIGATION WAS PERFORMED. THE CUSTOMER REPORTED LOW RESULTS WHEN TESTING THE IQC "VIROTROL" FROM BIORAD WITH IDAS CMV IGM LOT 1005685430(1.61 VT, 0.96 VT, 1.04 VT, 1.11 VT AND 1.01 VT) COMPARED TO THE SPECIFICATION THE CUSTOMER PUT IN PLACE BASED ON RESULTS OBTAINED ON PREVIOUS LOTS. A REVIEW OF QUALITY RECORDS CONFIRMED THERE WAS NO ISSUE IN THE PRODUCTION OF LOT 1005685430. AN ANALYSIS OF THE CONTROL CHART FOR 5 INTERNAL SAMPLES (TARGET : 1.84 - 1.27 - 2.08 - 1.07 - 0.31 TV) ON 9 DIFFERENT BATCHES OF VIDAS CMVM, SHOWED THAT VIDAS CMV IGM LOT 1005685430/180320-0 WAS IN THE TREND OF THE OTHER BATCHES. THE QUALITY PRODUCT LABORATORY TESTED THESE 5 INTERNAL SAMPLES ON THE RETAINED KIT OF VIDAS CMV IGM LOT 1005685430 AND OBTAINED THE FOLLOWING RESULTS : CM34 : 1.70 TV, CM26 : 1.13 TV, CM29 : 1.86 TV, CM104 0.85 TV, CM15 : 0.29 TV. ALL THE RESULTS WERE WITHIN THE SPECIFICATIONS AND SIMILAR TO THOSE OBTAINED BEFORE THE RELEASE OF THE BATCH VIDAS CMV IGM LOT 1005685430. THERE WAS NO DRIFT OF LOT 1005685430. THE QUALITY PRODUCT LABORATORY HAD TESTED THE IQC BIORAD VIROTROL WITH THE VIDAS CMVM LOT 180320-0 (RETAIN KIT) AND LOT 171203-0 (REFERENCE KIT). THE RESULTS WERE POSITIVE WITH THE 2 BATCHES. BATCH 171203-0: 1.43 TV. BATCH 180320-0: 1.04 TV. THE DIFFERENCES OBSERVED ARE LINKED TO THE NORMAL INTER-LOT VARIABILITY WHICH HAS NO IMPACT ON PATIENT RESULT OR INTERPRETATION STATUS. THE IQC VIROTROL IS MANUFACTURED (NOT NATURAL SAMPLE) AND MANUFACTURING PROCESS CAN AFFECT SAMPLE MATRIX, SO THE HYPOTHESIS IS THAT THIS SAMPLE COULD BEHAVE DIFFERENTLY FOLLOWING SOME LOTS OF VIDAS CMVM. IT IS RECOMMENDED THAT EACH LABORATORY ESTABLISHES ITS OWN RANGE FOR EACH ANALYTE (EXTRACT FROM PACKAGE INSERT VIROTROL TORCH-M). THE QUALITY PRODUCT LABORATORY RECOMPUTED THE FOLLOWING RANGE BASED ON THE CUSTOMER'S DATA (3 DISCREPANT VALUES OUT OF 96 VALUES NOT TAKEN INTO ACCOUNT BECAUSE VISIBLY OUT OF TREND 3.32TV, 3.54 TV, 2.19 TV) : MEAN : 1.485 TV, 2ET : [1.164-1.806] TV, 3ET : [1.003-1.967] TV. ACCORDING TO THIS NEW STATISTICS, CUSTOMER'S VALUES EXCLUDING 3 DISCREPANT VALUES CONFORM WITHIN RANGE AT 3 ET (EXCEPT FOR ONE VALUE AT 0,96 VT). CHECK WITH THE CUSTOMER HOW STATISTICS ARE COMPUTED AND SUGGEST THE CUSTOMER THAT IS ALSO POSSIBLE TO WORK WITH A MOBILE MEAN. QUALITY PRODUCT LABORATORY ANALYZED COMPLAINTS ABOUT SENSITIVITY PROBLEM (POTENTIAL FALSE NEGATIVE RESULT) SINCE 2013 AND OBSERVED THAT THERE IS NO INCREASE OF COMPLAINTS. BASED ON COMPLAINTS, THE RELATIVE SENSITIVITY IS ABOUT 99.99 % AND CONFORM TO PACKAGE INSERT PERFORMANCES (SENSITIVITY: 90.24 %). ACCORDING TO THE DATA MENTIONED ABOVE, VIDAS CMV IGM LOT 1005685430/180320-0 IS WITHIN THE EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® CMV IGM (REFERENCE (B)(4)). THE CUSTOMER REPORTED OUT OF RANGE RESULTS WHILE TESTING A PATIENT SAMPLE ASSOCIATED WITH VIDAS® CMV IGM. THE TEST RESULTS WERE: THE RANGES DEFINED BY THE LAB ARE THE FOLLOWING: AVERAGE: 1.423, SD: 0.1175. ACCEPTABLE LIMITS: 2 ET: 1.188-1.658, 3 ET: 1.0705-1.7755. CIQ RESULTS ON THE NEW BATCH: 1.34 / 1.07 / 1.2. RECALCUL OF AVERAGE AND SD ON ALL VALUES: AVERAGE 1.37, SD: 0.16, CV: 11.7% => NO ACCEPTABLE FOR THE CUSTOMER => 7% MAX. 29/06: 0.95 POSITIVE WITH BATCH 171213-0. 20/07: 0.79 EQUIVOCAL WITH BATCH 180328-0.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    625647 VIDAS® CMV IGM VIDAS® CMV IGM, LKQ BIOMERIEUX SA 30205 1005712890

    Patients

    Seq Age Sex Outcome Treatment
    1