BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TOXO IGM

    MDR report key: 1823440 · Received September 2, 2010

    Report

    Report Number
    1415939-2010-00400
    Event Type
    Malfunction
    Date Received
    September 2, 2010
    Report Date
    August 13, 2010
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LGD
    PMA / PMN Number
    K954576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED FOR AN INTERNATIONAL PRODUCT (B)(4) THAT HAS A SIMILAR PRODUCT DISTRIBUTED IN THE US (B)(4). AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED FALSE POSITIVE RESULTS FOR THE AXSYM TOXO-IGM ASSAY SINCE REPLACING THE REAGENT WITH A NEW LOT. NO SPECIFIC NUMBER OF PATIENTS WAS PROVIDED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOXO IGM FOR THE MEASUREMENT OF IGM ANTIBODIES TO TOXOPLASMA GONDII LGD ABBOTT LABORATORIES 84549HN01

    Patients

    Seq Age Sex Outcome Treatment
    1 AXSYM ANALYZER, 7A83-01, SN (B)(4)| AXSYM ANALYZER, 7A83-01, SN (B)(4)