BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1063545 · Received June 19, 2008

    Report

    Report Number
    1628664-2008-00147
    Event Type
    Malfunction
    Date Received
    June 19, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    MMI
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE ACCOUNT STATED THAT THE AXSYM ANALYZER GENERATED A DISCREPANT TROPONIN RESULT ON A PATIENT SAMPLE. THE INITIAL RESULT WAS 0.000 NG/ML AND THE REPEATED RESULT WAS 0.400 NG/ML. 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 MMI ABBOTT MANUFACTURING, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI