BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 677141 · Received February 7, 2006

    Report

    Report Number
    1628664-2006-00011
    Event Type
    Other
    Date Received
    February 7, 2006
    Report Date
    January 19, 2006
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER HAS BEEN PERFORMING A COMPARISON STUDY WITH THE AXSYM ANALYZER AND ANOTHER METHODOLOGY. THE CUSTOMER IS USING SAMPLES COLLECTED AND STORED FROZEN OVER THE PAST YEAR. THE COMPARISON METHODOLOGY GENRATED A REACTIVE S/CO RESULT OF 2.69. THE AXSYM AG/AB COMBO ASSAY GENERATED A NON-REACTIVE RESULT. PER THE CUSTOMER, THIS IS THE FIRST TIME THIS ISSUE WAS REPORTED TO ABBOTT. THERE IS NO IMPACT TO PT MANAGEMENT.

    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