BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 275187 · Received April 20, 2000

    Report

    Report Number
    1628664-2000-00022
    Event Type
    Other
    Date Received
    April 20, 2000
    Date of Event
    March 9, 2000
    Report Date
    April 14, 2000
    Manufacturer
    ABBOTT MFG, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ACCOUNT REPORTED OUT AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN VALUE OF 7235 MLU/ML. PHYSICIAN QUESTIONED RESULT. UPON RETEST, THE SAMPLE YIELDED A VALUE OF LESS THAN 5 MLU/ML. THERE WAS NO REPORT OF IMPACT ON PT MANAGEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT AXSYM SYSTEM MEIA FOR THE DETERMINATION OF HCG JJE ABBOTT MFG, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR LIST NUMBER 7A59-22.| AXSYM BETA-HUMAN CHORIONIC GONADOTROPHIN ASSAY,