BEUDAMED
    FDA Adverse Event Other Summary report: N

    TESTPACK PLUS HCG-COMBO

    MDR report key: 232657 · Received July 19, 1999

    Report

    Report Number
    1451914-1999-00007
    Event Type
    Other
    Date Received
    July 19, 1999
    Date of Event
    May 17, 1999
    Report Date
    July 16, 1999
    Manufacturer
    ABBOTT LABORATORIES, INC.
    Product Code
    JHJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    ON 06/02/1999 THE ACCOUNT OBTAINED A NEGATIVE TESTPACK PLUS HCG COMBO RESULT FOR A SERUM SAMPLE FROM A PATIENT.A SONOGRAM PERFORMED ON 06/02/1999 REVEALED THE PATIENT WAS APPROXIMATELY 9 WEEKS PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TESTPACK PLUS HCG-COMBO RAPID PREGNANCY TEST JHJ ABBOTT LABORATORIES, INC. NA 50400M300

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN