BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® CMV IGM

    MDR report key: 7702923 · Received July 19, 2018

    Report

    Report Number
    3002769706-2018-00111
    Event Type
    Malfunction
    Date Received
    July 19, 2018
    Report Date
    September 26, 2018
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LKQ
    PMA / PMN Number
    K933549
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE BATCH HISTORY RECORD FOR VIDAS CMV IGM LOT 1006302830 / 181229-0 WAS REVIEWED AND THERE ARE NO ANOMALIES LINKED TO THE CUSTOMER COMPLAINT. THE ANALYSIS OF THE CONTROL CHART FOR SIX (6) INTERNAL SAMPLES ON FIVE (5) DIFFERENT BATCHES OF VIDAS CMVM, SHOWED THAT VIDAS CMV IGM LOT 1006302830 / 181229-0 WAS IN ALIGNMENT WITH OTHER BATCHES. CM29, POS, TARGET 2.08 VT CM12, NEG, TARGET 0.05 VT CM39, EQUI, TARGET 0.80 VT CM20, POS, TARGET 0.97 VT CM23, NEG, TARGET 0.55 VT CM26, POS, TARGET 1.27 VT. THE COMPLAINTS LABORATORY TESTED SIX (6) INTERNAL SAMPLES WITH THE RETAINED VIDAS CMV IGM LOT 1006302830 / 181229-0 (3 POSITIVES SAMPLE= CM22, CM26 ET CM56, 2 EQUIVOCAL SAMPLE = CM52 ET CM105 ET 1 NEGATIVE SAMPLE = CM68). CM22, POS, TARGET 0.99 VT CM26, POS, TARGET 1.27 VT CM56, POS, TARGET 1.05 VT CM52, EQUI, TARGET 0.73 VT CM105, EQUI, TARGET 0.89 VT CM68, NEG, TARGET 0.05 VT. ALL THE RESULTS WERE FOUND WITHIN THEIR EXPECTED RANGE. ALSO, THE COMPARISON BETWEEN THESE RESULTS ON 31JUL2018 AND THE CONTROL OF ACTIVITY ON 15FEB2018, BEFORE RELEASE DID NOT SHOW ANY CHANGES FOR THE LOT IN QUESTION. WITHOUT THE CUSTOMER'S RETURN SAMPLE, WE CANNOT PURSUE INVESTIGATION NOR PROPOSE A ROOT CAUSE FOR THE CUSTOMER'S ISSUE. MOREOVER VIDAS RESULTS SHOULD HAVE BEEN CONFIRMED BY A THIRD METHOD, AS FOR EXAMPLE COBAS E411. VIDAS CMV IGM HAS NOT BEEN VALIDATED FOR USE WITH SPECIMENS COLLECTED POST MORTEM OR NEONATAL SPECIMENS (CORD BLOOD, ETC.) BUT A SPECIFICITY STUDY WAS CARRIED OUT USING 171 SERUM SAMPLES WITH 11 SERUM SAMPLES FROM INFANTS LESS THAN THREE (3) MONTHS OLD. WE RECORDED ONE (1) FALSE NEGATIVE RESULTS ON 4600 KITS COMMERCIALIZED SO 138 000 TEST, THE SENSIBILITY RECALCULATES OF THIS LOT IS 99.99%. THE SENSITIVITY GIVEN BY THE NOTICE IS AT 90.24% AND WITH 95% CONFIDENCE INTERVAL BETWEEN 76.87 - 97.28%. NO PERFORMANCE PROBLEM WAS IDENTIFIED FOR THE VIDAS CMV IGM LOT 1006302830 / 181229-0.

    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 RUNNING THE TEST ON ABBOTT ARCHITECT AND GOT A POSITIVE IGM RESULT (1.15 AU/ML) AND A POSITIVE IGG RESULT (200 AU/ML). THE RESULTS WERE ALSO RUN ON VIDAS® AS A SECOND METHOD AND THE RESULTS WERE NEGATIVE (0.55 AU/ML) IGM AND POSITIVE IGG (26 AU/ML), AND A LOW AVIDITY RESULT OF 0.26 AU/ML. PATIENT RESULTS WERE IMPACTED. IT IS UNKNOWN IF THE RESULT WAS REPORTED TO THE TREATING PHYSICIAN. THERE WAS A DELAY IN REPORTING RESULTS DUE TO THIS DISCREPANCY. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544039 VIDAS® CMV IGM VIDAS® CMV IGM LKQ BIOMERIEUX SA 1006302830

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR