BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 622931 · Received July 19, 2005

    Report

    Report Number
    1628664-2005-00030
    Event Type
    Other
    Date Received
    July 19, 2005
    Date of Event
    June 10, 2005
    Report Date
    July 18, 2005
    Manufacturer
    ABBOT MANUFACTURING, INC.
    Product Code
    LCI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A NEGATIVE AXSYM HCV RESULT ON A PATIENT WHO PREVOIUSLY TESTED AXSYM HCV REACTIVE. EVERY YEAR THE PATIENT TESTS AXSYM HCV REACTIVE (S/CO =2.2). THIS TIME, THE PATIENT TESTED AXSYM HCV NEGATIVE (S/CO =0.7). NO ADDITIONAL TESTING WAS PERFORMED ON THE SPECIMEN. NO PATIENT CLINICAL INFORMATION IS AVAILABLE. THE NEGATIVE AXSYM HCV RESULT WAS NOT REPORTED OUTSIDE OF THE LABORATORY. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN