BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6631933 · Received June 9, 2017

    Report

    Report Number
    3002769706-2017-00131
    Event Type
    Malfunction
    Date Received
    June 9, 2017
    Report Date
    July 24, 2017
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K141133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN INTERNAL BIOMÉRIEUX INVESTIGATION WAS PERFORMED WITH RESULTS AS FOLLOWS: THE COMPLAINT IS ABOUT EXTERNAL QUALITY CONTROLS FROM CTCB ( CENTRE TOULOUSAIN POUR LE CONTRÔLE DE QUALITÉ EN BIOLOGIE CLINIQUE - EQA FRENCH PROVIDER): CTCB TOXO 171 - SAMPLE 1711 PROVIDED A NEGATIVE RESULT BY THREE (3) PARTICIPANTS WHEREAS THE EXPECTED RESULT WAS TO BE POSITIVE REGARDING VIDAS® TOXO IGM REFERENCE (B)(4). THE RESULTS FOR CTCB TOXO 171 - SAMPLE 1711 WERE AS FOLLOWS : 75 PARTICIPANTS GAVE A POSITIVE RESULT AS EXPECTED, 24 PARTICIPANTS GAVE AN EQUIVOCAL RESULT, 3 PARTICIPANTS GAVE A NEGATIVE RESULT. A DISCREPANCY OR ANOMALY WAS NOT DETECTED DURING A REVIEW OF THE DEVICE HISTORY RECORD FOR THE THREE (3) VIDAS® TOXO IGM LOTS TESTED INTERNALLY BY BIOMERIEUX (BATCHES 170608-0 / 171213-0 SELECTED BY QP AND 170718-0 MENTIONED BY CUSTOMER). COMPLEMENTARY AVIDITY TESTING WAS PERFORMED INTERNALLY FOR AN EXTERNAL QUALITY CONTROL (CTCB TOXO 171 SAMPLE 1711) AND THE RESULT CONCLUDED HIGH AVIDITY. BASED ON THE PACKAGE INSERT, A RESULT OF AVIDITY HIGHER THAN 0.300 INDICATES AN OLD INFECTION (OLDER THAN 4 MONTHS). THEREFORE WE CONCLUDE THAT THE RESULTS ARE LIKELY FROM AN OLD INFECTION FOR AN EXTERNAL QUALITY CONTROL (CTCB TOXO 171 SAMPLES 1712). THIS CONCLUSION IS COHERENT WITH THE AGE OF PREGNANCY INDICATED IN CTCB REPORT (10 WEEKS FOR SAMPLE 1711). HYPOTHESIS : EQA CTCB 171 SAMPLE 1712 CONTAINS RESIDUAL IGM WHICH ARE NOT DETECTED BY VIDAS® TECHNIQUE. VIDAS® TOXO IGM DETECTS IGM FOR A SHORTER PERIOD OF TIME THAN COMPETITOR ASSAYS. IT IS ACCEPTABLE TO OBTAIN A SUSPECT RESULT IN CONTEXT OF AN OLD INFECTION, THERE IS A GREATER LIKELIHOOD WHEN THE SENSITIVITY IS GREATER THAN 90% IN THE CONTEXT OF A RECENT INFECTION (CNR PUBLICATION - J. CLIN. MICROBIOL.-2016-VILLARD-3034-42). REMINDER : EXTERNAL QUALITY CONTROLS ARE COMPOSED OF HUMAN MATRIX. EQA ARE MANUFACTURED AND CANNOT BE CONSIDERED AS NATURAL SAMPLES FROM PATIENT. CONCLUSION: THERE IS NO PRODUCT PERFORMANCE ISSUE. THE PRODUCT MEETS ITS EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® TOXO IGM (REFERENCE (B)(4)). THE CUSTOMER REPORTED THAT NEGATIVE RESULTS WERE OBTAINED WHILE THE EXPECTED RESULT WAS POSITIVE AS PART OF EEQ CTCB 171. THERE IS NO PATIENT ASSOCIATED WITH THIS TEST RESULT BECAUSE THE TESTING WAS PART OF EEQ CTCB. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411372 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX SA 30202

    Patients

    Seq Age Sex Outcome Treatment
    1