BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6177580 · Received December 15, 2016

    Report

    Report Number
    3002769706-2016-00514
    Event Type
    Malfunction
    Date Received
    December 15, 2016
    Report Date
    November 22, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LYR
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED TO BIOMÉRIEUX THAT THEY HAVE OBSERVED FALSE NEGATIVE RESULTS, AS PART OF EQA TOXO 163, IN ASSOCIATION WITH THE VIDAS® TOXO IGM TEST. THE CUSTOMER INDICATED THE SERUM IS A KNOWN POSITIVE AND THE TEST RESULTS WERE: 0.49 => NEGATIVE. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS CONDUCTED. THE COMPLAINT IS ABOUT THE (B)(6) EQA TOXO 163 FROM CTCB (CENTRE TOULOUSAIN POUR LE CONTRÔLE DE QUALITÉ EN BIOLOGIE CLINIQUE) FOUND NEGATIVE BY THE MAJORITY OF PARTICIPANTS WHEREAS IT WAS EXPECTED TO BE POSITIVE WITH VIDAS® TOXO IGM REFERENCE (B)(4). RESULTS FOR THIS CONTROL CTCB TOXO 163 ARE AS FOLLOWS : (B)(6) PARTICIPANTS GAVE A POSITIVE RESULT AS EXPECTED, (B)(6) PARTICIPANTS GAVE AN EQUIVOCAL RESULT, (B)(6) PARTICIPANTS GAVE A NEGATIVE RESULT. THE STUDY OF BATCH HISTORY RECORD FOR VIDAS® TOXO IGM LOTS 1004881890 / 170306-0 SHOWS NO ANOMALY DURING THE CONTROL PROCESS. THE QUALITY PRODUCT LABORATORY OBSERVED CONTROL CHARTS FOR 5 INTERNAL SAMPLES FROM QUALITY CONTROL DEPARTMENT FOR 6 LOTS OF VIDAS® TOXO IGM. ALL THE RESULTS ARE WITHIN EXPECTED RANGES AND ALL BATCHES ARE WITHIN THE TREND OF THE PARAMETER. QUALITY PRODUCT DEPARTMENT TESTED THE CONTROL CTCB TOXO 163 AND FOUND AN EQUIVOCAL RESULT ON A DIFFERENT VIDAS® TOXO IGM LOT. QUALITY PRODUCT DEPARTMENT CONFIRMS RESULTS INDICATED IN CTCB REPORT. COMPLEMENTARY RESULTS ARE INDICATED IN CTCB REPORT FOR CONTROL CTCB TOXO 163 : VIDAS® TOXO IGG II : 95 UI/ML POSITIVE (PRE-TESTING RESULT), VIDAS® TOXO IGG AVIDITY : 0410 TV HIGH (PRE-TESTING RESULT), TOXO ISAGA POSITIVE (RESULT FOUND BY 12/12 PARTICIPANTS). AN RESULT OF AVIDITY HIGHER THAN 0.300 INDICATES AN OLD INFECTION, OLDER THAN 4 MONTHS. QUALITY PRODUCT CONCLUDE TO A PROBABLE OLD INFECTION FOR CONTROL CTCB TOXO 163. THIS CONTROL COULD CONTAIN RESIDUAL IGM WHICH ARE NOT DETECTED BY VIDAS® TECHNIQUE. THIS CONCLUSION MATCHES WITH THE CONCLUSION PROPOSED BY THE CTCB IN THE REPORT. VIDAS® TOXO IGM LOTS1004881890 / 170306-0 PERFORMED AS EXPECTED. AN ANOMALY WAS LINKED TO THE CONTROL CTCB TOXO 163 WHICH PROBABLY CONTAINS RESIDUAL IGM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828323 VIDAS® TOXO IGM VIDAS® TOXO IGM LYR BIOMERIEUX SA 1004881890

    Patients

    Seq Age Sex Outcome Treatment
    1