BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 296509 · Received September 12, 2000

    Report

    Report Number
    1451914-2000-00007
    Event Type
    Other
    Date Received
    September 12, 2000
    Date of Event
    August 2, 2000
    Report Date
    September 8, 2000
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT REPORTED A NEGATIVE TESTPACK PLUS HCG URINE RESULT ON A FIRST MORNING URINE SPECIMEN. SAMPLE WAS TESTED AT ANOTHER LAB AND POSITIVE RESULTS WERE OBTAINED USING "BABYCHECK", A QUALITATIVE URINE ASSAY. THE PT HAS BEEN CONFIRMED PREGNANT. NO IMPACT TO PT MANAGEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-URINE RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES NA 63698M200

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Other