BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCANTIBODIES LABORATORY, INC.

    MDR report key: 499033 · Received November 24, 2003

    Report

    Report Number
    MW1030368
    Event Type
    Malfunction
    Date Received
    November 24, 2003
    Date of Event
    November 15, 2003
    Report Date
    November 19, 2003
    Manufacturer
    SCANTIBODIES LABORATORY, INC.
    Product Code
    LCX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    FIRST RESPONSE EARLY RESPONSE PREGNANCY DOUBLE PACK WITH BONUS TEST GAVE REPORTER A FALSE POSITIVE TEN DAYS AFTER OVULATION. CONFIRMATION WITH OTHER BRANDS AND A BETA TEST AND SUBSEQUENT MENSTRUATION CONFIRMED REPORTER IS NOT PREGNANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCANTIBODIES LABORATORY, INC. FIRST RESPONSE EARLY RESULT PREG LCX SCANTIBODIES LABORATORY, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other