BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG

    MDR report key: 5633569 · Received May 5, 2016

    Report

    Report Number
    3002769706-2016-00084
    Event Type
    Malfunction
    Date Received
    May 5, 2016
    Report Date
    April 27, 2016
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMÉRIEUX OF UNREPEATABLE DILUTION RESULTS WITH VIDAS® TOXO IGG 1004509770/161027-0 AND "INVALID" RESULTS WITH VIDAS® TOXO IGG AVIDITY . THE HIGH LEVEL OBTAINED WITH VIDAS® TOXO IGG DID NOT ALLOW PERFORMANCE OF THE AVIDITY ASSAY WITH THE DILUTION CALCULATED AS INDICATED IN THE PACKAGE INSERT OF VIDAS TOXO IGG AVIDITY. INTERNAL INVESTIGATION RESULTS ARE AS FOLLOWS: NO ANOMALY IN THE BATCH HISTORY RECORD OF VIDAS® TXG II 1004509770/161027-0 LINKED TO THIS COMPLAINT. NO NON-CONFORMITY LINKED TO THE CUSTOMER ANOMALY. THREE (3) OTHER COMPLAINTS REGISTERED ON VIDAS® TXG II 1004509770/161027-0 FOR THE SAME ISSUE. CAPA WAS INITIATED FOR DILUTION TESTS ON POSITIVE SERA NOT CONSISTENT WITH PURE TITLES OBTAINED ON DIFFERENT BATCHES OF VIDAS® TOXO IGG.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) NOTIFIED BIOMERIEUX OF A DISCREPANT RESULT ASSOCIATED WITH VIDAS TOXO IGG (REFERENCE 30210). THE CUSTOMER REPORTED RESULTS TXM 2,64 AND TXG 175 IU/ML FOR A PREGNANT WOMAN. THE PATIENT ONLY RECEIVED THE RESULTS FOR TXM AND TXG WITH ANNOTATION. THERE IS NO REPORT OF ADVERSE IMPACT TO PATIENT STATE OF HEALTH. AN INTERNAL BIOMEREUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288844 VIDAS® TOXO IGG VIDAS® TOXO IGG LGD BIOMERIEUX SA 1004509770

    Patients

    Seq Age Sex Outcome Treatment
    1