BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 665691 · Received January 13, 2006

    Report

    Report Number
    1628664-2006-00005
    Event Type
    Other
    Date Received
    January 13, 2006
    Date of Event
    December 27, 2005
    Report Date
    January 12, 2006
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JJE
    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 PT SAMPLE IS GENERATING ERRATIC RESULTS WITH THE AXSYM TOXO IGM ASSAY. THE SAME PT SAMPLE GENERATED INDEX RESULTS OF 0.099 (NEGATIVE), 0.683 POSITIVE), 0.110 (NEGATIVE), AND 0.109 (NEGATIVE). CONTROLS HAVE BEEN WITHIN SPECIFICATIONS. THE ANALYZER'S MESSAGE HISTORY LOG SHOWED A NUMBER OF LIQUID LEVEL SENSE ERRORS. A FIELD SERV ICE CALL WAS INITIATED. THERE IS NO IMPLACT TO PT MANAGEMENT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN