BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 6845855 · Received September 6, 2017

    Report

    Report Number
    3002769706-2017-00270
    Event Type
    Malfunction
    Date Received
    September 6, 2017
    Report Date
    September 6, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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 WHEN TESTING THE INTERNAL QUALITY CONTROL VIROTROL FROM BIO-RAD IN ASSOCIATION WITH VIDAS® CMV IGM. THE TEST RESULTS WERE: LOT 180119-0 : VALUES BETWEEN 0.72 AND 1.4 MEAN=0.85 (SD=0.15 AND CV=16%)=> ALL THE RESULTS HAVE A POSITIVE OR EQUIVOCAL INTERPRETATION FIRST (1ST) CALIBRATION S1 : 1236 RFV VALUES OBTAINED BETWEEN THE 5TH OF JUNE AND THE 12TH OF JUNE : 0.87 / 0.79/ 0.76 / 0.92 / 0.89 / 1.4 / 0.9 / 0.86. SECOND (2ND) CALIBRATION S1 : 1376 RFV VALUES OBTAINED BETWEEN THE 13TH AND THE 26TH OF JUNE : 0.85 / 0.81/ 0.78 / 0.79/ 0.81/0.80 / 0.72 /0.74 /0.81 /0.79. LOT 180320-0 : VALUES BETWEEN 0.63 AND 0.96 MEAN=0.76 (SD=0.76 AND CV=17%)==> SOME OF THEM ARE POSITIVE (0.96), SOME ARE EQUIVOCAL (0.75 AND 0.81), 2 HAVE A NEGATIVE INTERPRETATION (0.63 AND 0.66).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627127 VIDAS® CMV IGM VIDAS® CMV IGM, LKQ BIOMERIEUX SA 30205 1005685430

    Patients

    Seq Age Sex Outcome Treatment
    1