BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 296444 · Received September 12, 2000

    Report

    Report Number
    1451914-2000-00006
    Event Type
    Other
    Date Received
    September 12, 2000
    Date of Event
    July 27, 2000
    Report Date
    September 6, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT HAS REPORTED NEGATIVE TESTPACK PLUS HCG URINE RESULTS USING A FIRST MORNING URINE SPECIMEN ON THREE PTS. INFO IS ONLY AVAILABLE FOR ONE PT. POSITIVE HCG RESULTS WERE OBTAINED WITH HOME TESTING AND/OR SERUM TEST. QUANTITATIVE RESULTS WERE NOT AVAILABLE. LAST MENSTRUAL PERIOD WAS 6/29/2000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 60852M200

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO Other