BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 591835 · Received April 15, 2005

    Report

    Report Number
    1628664-2005-00014
    Event Type
    Other
    Date Received
    April 15, 2005
    Report Date
    April 14, 2005
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT BHCG RESULTS CAME OUT VERY HIGH ON ONE PATIENT RUN IN THEIR ERICSEL ANALYZER. THE SAMPLE WAS THEN RUN DILUTED 1:10 ON THE AXSYM ANALYZER WITH A RESULT OF 104 IL/L GENERATED. THE SAMPLE WAS REPEATED USING A 1:200 DILUTION ON THE AXSYM ANALYZER AND RESULTS OF 169,870 IU/L AND 171,700 IU/L WERE GENERATED. THE RESULT FROM THE 1:10 DILUTION WAS NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other AXSYM TOTAL BHCG REAGENT LIST NO. 7A59-21.