BEUDAMED
    FDA Adverse Event Other Summary report: N

    AXSYM TOXO IGM

    MDR report key: 580117 · Received October 4, 2004

    Report

    Report Number
    1415939-2004-00027
    Event Type
    Other
    Date Received
    October 4, 2004
    Date of Event
    August 23, 2004
    Report Date
    October 1, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    LGD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT THE FOLLOWING AXSYM RESULTS WERE GENERATED ON A PATIENT: 06/2004 TOXO G NEGATIVE <2 IU/ML, TOXO M NEGATIVE 08//2004 TOXO G GREYZONE 2 IU/ML, TOXO M NEGATIVE 0.49 INDEX VALUE 9 DAYS LATER TOXO G POSITIVE 8 IU/ML, TOXO M NEGATIVE 0.48 INDEX VALUE THE SAMPLE FROM 9 DAYS AFTER RETESTED TOXO M GREYZONE 0.56 INDEX VALUE ON AXSYM. SAMPLES WERE SENT OT ANOTHER FACILITY FOR CONFIRMATION TESTING. 08/2004 TOXO G DYE TEST POSITIVE, AGGLUTINATION <1, TOXO M POSITIVE ISAGA METHOD 9 DAYS SAMPLE TOXO G DYE TEST POSITIVE, AGGLUTINATION 2, TOXO M POSITIVE ISAGA METHOD THE CUSTOMER EXPECTED THE NEGATIVE AXSYM TOXO M RESULT ON LATER DAY TO BE HIGHER BECAUSE SEROCONVERSION WAS CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXSYM TOXO IGM MEIA FOR DETECTION OF IGM AB TO TOXOPLASMA LGD ABBOTT LABORATORIES NA 16163M300

    Patients

    Seq Age Sex Outcome Treatment
    1 NA AXSYM ANALYZER LIST NO. 7A83-01.