BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXSYM TOTAL BHCG

    MDR report key: 214227 · Received March 10, 1999

    Report

    Report Number
    1628664-1999-00014
    Event Type
    Malfunction
    Date Received
    March 10, 1999
    Date of Event
    January 20, 1999
    Report Date
    March 9, 1999
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 1/20/99 CUSTOMER OBTAINED A RUBELLA LGG RESULT OF 3.1 LU/ML. SAMPLE WAS REPEATED WITH RESULTS OF 105.4 LU/ML, 89.7 IU/ML AND 97.LU/ML. ORIGINAL RESULT WAS NOT REPORTED OUT OF LAB. NO REPORT OF IMPACT TO PT. NO TREATMENT GIVEN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NA