BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 1002788 · Received February 26, 2008

    Report

    Report Number
    1628664-2008-00063
    Event Type
    Malfunction
    Date Received
    February 26, 2008
    Date of Event
    January 24, 2008
    Report Date
    January 29, 2008
    Manufacturer
    ABBOTT MANUFACTURING INC.
    Product Code
    LOM
    PMA / PMN Number
    K950915
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    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 CUSTOMER STATED THAT THE AXSYM ANALYZER GENERATED A NEGATIVE AXSYM CORE RESULT (S/CO=1.144). THE SAMPLE WAS REPEATED THE NEXT DAY AND WAS REACTIVE IN DUPLICATE (S/CO=0.379 AND 0.402). THE NEGATIVE RESULTS WERE NOT REPORTED. THE SAMPLE WAS ALSO TESTED TWICE WITH HBSAG AND WAS REACTIVE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK AXSYM CORE REAGENT LOT# 57813LF00