BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6644879 · Received June 15, 2017

    Report

    Report Number
    3002769706-2017-00138
    Event Type
    Malfunction
    Date Received
    June 15, 2017
    Report Date
    July 25, 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

    A CUSTOMER IN FRANCE NOTIFIED BIOMÉRIEUX OF A FALSE NEGATIVE RESULT FOR AN EQA CTCB 1711 SAMPLE ASSOCIATED WITH VIDAS® TOXO IGM. AN INVESTIGATION WAS PERFORMED. THE REPORT FROM CTCB ( CENTRE TOULOUSAIN POUR LE CONTRÔLE DE QUALITÉ EN BIOLOGIE CLINIQUE - EQA FRENCH PROVIDER) WAS REVIEWED, WHEREAS, CTCB TOXO 171 - SAMPLE 1711, WAS FOUND NEGATIVE BY THREE PARTICIPANTS WHEN IT WAS EXPECTED TO BE POSITIVE WITH VIDAS® TOXO IGM (REFERENCE (B)(4)). 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 REVIEW OF QUALITY RECORDS CONFIRMED THE MANUFACTURING OF VIDAS® TOXO IGM LOTS, 170608-0 / 171213-0 / 180213-0 AND 170718-0, WERE WITHIN SPECIFICATION. THE CTCB TOXO 171 SAMPLE 1711 WAS TESTED AND THE RESULT WAS POSITIVE ON VIDAS® TOXO IGM LOTS 170608-0, 171213-0 AND LOT 180213-0. A COMPLEMENTARY AVIDITY TEST WAS PERFORMED FOR THE EXTERNAL QUALITY CONTROL CTCB TOXO 171 SAMPLE 1711, AND GAVE A HIGH AVIDITY RESULT. ACCORDING TO THE PACKAGE INSERT, A RESULT OF AVIDITY HIGHER THAN 0.300 INDICATES AN OLD INFECTION, OLDER THAN 4 MONTHS. THE CONCLUSION OF A PROBABLE OLD INFECTION FOR EXTERNAL QUALITY CONTROLS CTCB TOXO 171 SAMPLES 1712, IS COHERENT WITH THE AGE OF PREGNANCY INDICATED IN CTCB REPORT (10 WEEKS FOR SAMPLE 1711). HYPOTHETIS : 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 OTHER COMPETITORS. IT IS ACCEPTABLE TO OBTAIN A DOUBTFUL RESULT IN A CONTEXT OF OLD INFECTION, ESPECIALLY MORE THAN THE SENSITIVITY IS HIGHER THAN 90% IN THE CONTEXT OF A RECENT INFECTION (CNR PUBLICATION - J. CLIN. MICROBIOL.-2016-VILLARD-3034-42) . THE EXTERNAL QUALITY CONTROLS ARE COMPOSED OF HUMAN MATRIX. EQA ARE MANUFACTURED AND CANNOT BE CONSIDERED AS NATURAL SAMPLES FROM PATIENT. IN CONCLUSION, THERE IS NO PERFORMANCE ISSUE AND VIDAS® TOXO IGM PERFORMED AS EXPECTED.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF DISCREPANT RESULTS ASSOCIATED WITH VIDAS® TOXO IGM. THE CUSTOMER REPORTED THAT THEY OBTAINED A FALSE NEGATIVE RESULT. EQA CTCB 1711 WAS FIRST OBTAINED AT 0.69 (POSITIVE RESULT) (465 RFV) AND WAS RETESTED BY THE CUSTOMER AFTER CENTRIFUGATION AND THE RESULT OBTAINED WAS 0.63 (EQUIVOCAL RESULT)(424 RFV). THE RESULT OF 0.63 WAS TRANSMITTED TO THE CTCB. 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
    424990 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX SA 30202 1005385420

    Patients

    Seq Age Sex Outcome Treatment
    1