BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGG II

    MDR report key: 8706015 · Received June 17, 2019

    Report

    Report Number
    8020790-2019-00033
    Event Type
    Malfunction
    Date Received
    June 17, 2019
    Date of Event
    May 16, 2019
    Report Date
    September 15, 2019
    Manufacturer
    BIOMERIEUX SA
    Product Code
    LGD
    PMA / PMN Number
    K993319
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AN INTERNAL INVESTIGATION WAS PERFORMED FOR FALSE POSITIVE RESULTS IN ASSOCIATION WITH THE VIDAS® TOXO IGG II ASSAY (LOT 1002486324863), IN CORRELATION WITH CENTAUR (SIEMENS) AND ARCHITECT (ABBOTT). NO PATIENT SAMPLES WERE PROVIDED FOR EVALUATION. QUALITY CONTROL RECORDS: THERE WAS NO OTHER SIMILAR COMPLAINT ON THIS BATCH OF REAGENT VIDAS TXG, 1006706700/190621-0 RECORDED. NO CAPA NOR NONCONFORMITY WAS LINKED TO THE CUSTOMER'S COMPLAINT RECORDED ON VIDAS TXG. ANALYSIS OF THE BATCH HISTORY RECORDS SHOWN NO ANOMALY DURING THE MANUFACTURING, CONTROL AND PACKAGING PROCESSES. A STUDY OF INTERNAL SAMPLE CONTROL CHARTS ON THREE INTERNAL NEGATIVE SAMPLES AND ONE INTERNAL POSITIVE SAMPLE WITH SIX DIFFERENT LOTS OF VIDAS TXG INCLUDING CUSTOMER'S LOT, SHOWED ALL RESULTS WERE WITHIN EXPECTED SPECIFICATIONS. VIDAS TXG LOT 1006706700/190621-0 WAS IN THE TREND OF THE OTHER LOTS. TESTS PERFORMED BY COMPLAINT LABORATORY : FOUR INTERNAL SAMPLES WERE TESTED ON VIDAS TXG LOT 1006706700/190621-0, AND ALL THE RESULTS CONFORMED. THE RESULTS WERE SIMILAR TO THOSE OBTAINED BEFORE THE BATCH RELEASE. NO INTERPRETATION CHANGE AND NO DRIFT OF THE LOT SINCE BATCH RELEASE WAS OBSERVED. CONCLUSION: WITHOUT A RETURN SAMPLE, IT'S DIFFICULT TO CONCLUDE ON THIS BAD CORRELATION, AND PROBABLE SPECIFICITY ISSUE FOR VIDAS TOXO IGGII ASSAY ON THOSE PATIENT SAMPLES. THE MAIN HYPOTHESIS TO EXPLAIN THE FALSE POSITIVE RESULTS OBTAINED WITH VIDAS TOXO IGG II MAY BE LINKED TO THE PRESENCE OF AN INTERFERENCE IN THESE PARTICULAR SAMPLES (MOTHER AND NEW BORN), LEADING TO A VERY LOW LEVEL OF POSITIVITY OF THE VIDASTOXO IGGII TEST. VIDAS TXG, REF 30210 PACKAGE INSERT: "LIMITATIONS OF THE METHOD" "7. INTERFERENCE MAY BE ENCOUNTERED WITH CERTAIN SERA CONTAINING ANTIBODIES DIRECTED AGAINST REAGENT COMPONENTS. FOR THIS REASON, ASSAY RESULTS SHOULD BE INTERPRETED TAKING INTO CONSIDERATION THE PATIENT HISTORY, AND THE RESULTS OF ANY OTHER TESTS PERFORMED." ACCORDING TO THE INFORMATION ABOVE, VIDAS TOXO IGG II, LOT 1006706700/190621-0 IS STILL WITHIN ITS EXPECTED PERFORMANCES.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) REPORTED FALSE POSITIVE RESULTS FOR A FEMALE PATIENT IN ASSOCIATION WITH THE VIDAS® TOXO IGG II ASSAY (LOT 1002486324863). THE FEMALE PATIENT WAS KNOWN TO HAVE NEGATIVE RESULTS FOR TOXO IGG (CHEMOLUMINESCENCE BY ARCHITECT) DURING HER PREGNANCY. AFTER DELIVERY, A SAMPLE WAS DRAWN, AND THE TEST RESULT ON (B)(6) 2019 WAS TOXO IGG POSITIVE (16UI/ML) USING VIDAS. A NEW SAMPLE FROM THE PATIENT WAS RETESTED FOR TOXO IGG IN ANOTHER LABORATORY (METHOD UNKNOWN) WHICH WAS REPORTED TO BE NEGATIVE BY ARCHITECT METHOD. THERE IS NO INDICATION OR REPORT FROM THE HOSPITAL OR TREATING PHYSICIAN TO BIOMÉRIEUX THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. A BIOMÉRIEUX INTERNAL INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497621 VIDAS® TOXO IGG II VIDAS® TOXO IGG II LGD BIOMERIEUX SA 1006706700

    Patients

    Seq Age Sex Outcome Treatment
    1