BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 628173 · Received August 12, 2005

    Report

    Report Number
    1628664-2005-00034
    Event Type
    Other
    Date Received
    August 12, 2005
    Date of Event
    July 21, 2005
    Report Date
    August 12, 2005
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATES THAT ONE MONTH AGO, A PATIENT GENERATED A NEGATIVE AXSYM TOXO IGM ASSAY INDEX RESULT OF 0.360 (THE TOXO IGG ASSAY RESULT WAS POSITIVE AT 80 IU/ML). PRESENTLY, A NEW SAMPLE DRAWN FROM THIS SAME PATIENT GENERATED A POSITIVE AXSYM TOXO IGM ASSAY INDEX RESULT OF 1.572 (THE TOXO IGG ASSAY RESULT WAS POSITIVE AT 82 IU/ML). BOTH SAMPLES WERE TESTED BY AN ALTERNATE METHODOLOGY (ELISA) AND GENERATED SIMILAR RESULTS. BOTH SAMPLES WERE THEN SENT TO A TOXO REFERENCE CENTER AND BOTH SAMPLES TESTED NEGATIVE FOR TOXO IGM (THE TOXO IGG RESULTS WERE SIMILAR). THERE IS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM AUTOMATED IMMUNOASSAY ANALYZER JHI ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN