BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-URINE

    MDR report key: 516402 · Received January 23, 2004

    Report

    Report Number
    1451914-2004-00001
    Event Type
    Other
    Date Received
    January 23, 2004
    Date of Event
    December 18, 2003
    Report Date
    January 21, 2004
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE ACCOUNT GENERATED A NEGATIVE TESTPACK PLUS HCG URINE RESULT USING A RANDOM URINE ON A PT WITH A MISSED MENSES. IN 2003 THE PT TESTED HCG POSITIVE WITH AN OVER THE COUNTER PREGNANCY TEST. THE FOLLOWING DAY THE PT TESTED TESTPACK PLUS HCG URINE NEGATIVE USING A RANDOM URINE SPECIMEN. THE NEXT DAY THE PT AGAIN TESTED HCG POSITIVE WITH AN OVER THE COUNTER PREGNANCY TEST AND BAYER HCG = 962.2 MIU/ML. FOUR DAYS LATER THE PT TESTED HCG QUANTITATION = 5563 MIU/ML (UNKNOWN METHOD). CURRENTLY, THE PT IS PREGNANT WITH TWINS. 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 92684M200

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR