BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® EBV VCA IGM

    MDR report key: 5458128 · Received February 24, 2016

    Report

    Report Number
    3002769706-2016-00040
    Event Type
    Malfunction
    Date Received
    February 24, 2016
    Report Date
    February 15, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K092587
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE NEGATIVE RESULTS WHILE USING VIDAS® EBV VCA IGM LOT 1004235770 / 160715-0. AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: ONE COMPLAINT FOR THE KIT VIDAS® EBV VCA IGM LOT 1004235770/160715-0 WAS RECORDED FOR A TOTAL OF 2426 KITS RELEASED IN THE FIELD. REVIEW OF BATCH RECORD HISTORY- NO NONCONFORMITIES FOR THIS LOT. TESTING OF THE KIT VIDAS® EBV VCA IGM LOT 1004235770/160715-0 IN THE RETURNED SAMPLE WAS NOT POSSIBLE DUE TO VOLUME OF SAMPLE WAS NOT SUFFICIENT . NO PRESENCE OF IGM ANTI P18 WERE IN THE RETURN SAMPLE. THE NEGATIVE RESULT OBTAINED WITH THE KIT VIDAS® EBV VCA IGM BY THE CUSTOMER ARE IN ACCORDANCE WITH THE RESULTS OBTAINED WITH ALL DIAG EBVCHECK IGM AND IGG. THE CUSTOMER COMPARED THE NEGATIVE RESULTS OBTAINED ON THE VIDAS® VCA IGM KIT WITH THE POSITIVE RESULTS OBTAINED ON THE CHEMILUMINESCENCE TECHNIQUE COMBO (ANTICORPS ANTI EPSTEIN-BARR / ANTIGENE CAPSID VCA IGM). MOREOVER, THE CUSTOMER OBTAINED NEGATIVE RESULTS ON THE CHEMILUMINESCENCE TECHNIQUE (ANTICORPS ANTI EPSTEIN BARR EA) EARLY. THE NEGATIVE RESULTS OBTAINED ARE IN ACCORDANCE WITH THE RESULTS OBTAINED WITH THE VIDAS® VCA IGM KIT AND ALL DIAG EBVCHECK IGM AND IGG. THE POSITIVE RESULTS OBTAINED ON THE CHEMILUMINESCENCE TECHNIQUE COMBO SHOW THE PRESENCE OF ANTIGEN. WHEN THE CUSTOMER TESTED THE CHEMILUMINESCENCE TECHNIQUE (ANTICORPS ANTI ESPEIN BARR EA EARLY, NEGATIVE RESULTS WERE OBTAINED. CONCLUSION- VIDAS® EBV VCA IGM IS PERFORMING WITHIN THE EXPECTED SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6 )REPORTED FALSE NEGATIVE RESULTS FOR TWO PATIENTS WITH CLINICAL SYMPTOMS OF MONONUCLEOSIS DISEASE WHILE USING; VIDAS EBV VCA IGM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112667 VIDAS® EBV VCA IGM VIDAS® EBV VCA IGM LGD BIOMERIEUX SA 1004235770

    Patients

    Seq Age Sex Outcome Treatment
    1