BEUDAMED
    FDA Adverse Event Other Summary report: N

    ABBOTT AXSYM SYSTEM

    MDR report key: 112968 · Received August 11, 1997

    Report

    Report Number
    1628664-1997-00070
    Event Type
    Other
    Date Received
    August 11, 1997
    Date of Event
    July 8, 1997
    Report Date
    August 6, 1997
    Manufacturer
    ABBOTT MANUFACTURING, INC.
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 07/08/1997 THE ACCOUNT REPORTED A FALSE NEGATIVE RESULT FOR BHCG. THE INITIAL RESULT OBTAINED WAS 0.41 MIU/ML WHICH WAS REPORTED AS NEGATIVE. THE PHYSICIAN QUESTIONED THE RESULT AND THE SAMPLE WAS REPEATED BY THE ACCOUNT. A RETEST RESULT OF 63,000 MIU/ML WAS GIVEN. NO FURTHER INFORMATION HAS BEEN HAS BEEN PROVIDED BY THE ACCOUNT. NO REPORT OF INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO AXSYM BHCG REAGENT, LIST NUMBER 7A59-20.