BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIDAS® TOXO IGM

    MDR report key: 6259709 · Received January 18, 2017

    Report

    Report Number
    3002769706-2017-00006
    Event Type
    Malfunction
    Date Received
    January 18, 2017
    Report Date
    February 10, 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

    BIOMERIEUX CONDUCTED AN INTERNAL INVESTIGATION: A REVIEW OF DEVICE HISTORY RECORD FOR THIS LOT WAS PERFORMED AND NO DISCREPANCY OR ANOMALY WAS OBSERVED DURING THIS REVIEW. THE PRODUCT QUALITY LABORATORY ANALYZED CONTROL CHARTS FOR FIVE (5) INTERNAL SAMPLES (ONE NEGATIVE SAMPLE AND FOUR POSITIVE SAMPLES) FROM THE QUALITY CONTROL DEPARTMENT FOR NINE LOTS OF VIDAS TOXO IGM; ALL RESULTS WERE WITHIN THE EXPECTED RANGES AND ALL BATCHES WERE WITHIN SPECIFICATION. VIDAS TOXO IGM DETECTS IGM FOR A SHORTER PERIOD OF TIME. THE RESULTS ARE CONSISTENT, VIDAS TXM USERS FOUND A RESULT AROUND THE DOUBTFUL RANGE IN CONTEXT OF AN OLD INFECTION. THE SPECIFICITY OF THE REAGENT DOES NOT PREJUDGE ITS ABILITY TO DETECT IGM IN CASE OF A RECENT INFECTION. THE INVESTIGATION CONCLUDED THAT THE LOTS TESTED WERE WITHIN THE EXPECTED PERFORMANCE RANGES AND NO ADDITIONAL ACTION IS WARRANTED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A CUSTOMER IN (B)(6) CONTACTED BIOMÉRIEUX TO REPORT THE OCCURRENCE OF A FALSE NEGATIVE RESULT (0.49) FOR AN EXTERNAL QUALITY SURVEY SAMPLE (EAQ CTCB 1622) IN ASSOCIATION WITH THE VIDAS® TOXO IGM ASSAY. THE EXPECTED RESULT WAS POSITIVE (TARGET VALUE 0.65). VIDAS® TOXO IGM REFERENCE 30202 IS NOT SOLD IN THE UNITED STATES; HOWEVER, A SIMILAR PRODUCT VIDAS® TOXO IGM REFERENCE 30202-01 IS SOLD IN THE UNITED STATES. THERE IS NO INDICATION OR REPORT FROM THE LABORATORY THAT THE DISCREPANT RESULT LED TO ANY ADVERSE EVENT RELATED TO ANY PATIENT'S STATE OF HEALTH. THERE WAS NO PATIENT DIRECTLY ASSOCIATED WITH THE EAQ SURVEY SAMPLE. THERE MAY BE A POTENTIAL FOR ADVERSE EVENT IF THE EVENT WERE TO REOCCUR WHEN TESTING A PATIENT SPECIMEN; THEREFORE THIS EVENT IS BEING REPORTED AS A MALFUNCTION. AS THE BIOMÉRIEUX QUALITY LAB IS ENROLLED IN THIS EAQ TESTING, AN INTERNAL INVESTIGATION WILL BE CONDUCTED USING THE INTERNAL STRAIN. AN INTERNAL BIOMÉRIEUX INVESTIGATION WILL BE INITIATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45635 VIDAS® TOXO IGM VIDAS® TOXO IGM LGD BIOMERIEUX SA 1004614010

    Patients

    Seq Age Sex Outcome Treatment
    1