BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORSURE ONESTEP HCG PREGNANCY TEST KIT

    MDR report key: 2140507 · Received June 21, 2011

    Report

    Report Number
    MW5021100
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    June 13, 2011
    Report Date
    June 21, 2011
    Manufacturer
    AVENTIR BIOTECH, LLC
    Product Code
    JHI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PREGNANCY TEST DONE BY THE FORSURE TEST KIT BY AVENTIR BIOTECH, LLC, LOT 909312, EXP. 10/2011, WAS NEGATIVE ON 2 OCCASIONS AND THE BLOOD TEST WAS POSITIVE. PT'S OWN PREGNANCY TEST AT HOME WAS POSITIVE. THIS TEST IS GIVING INACCURATE INFO REGARDING PREGNANCY STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORSURE ONESTEP HCG PREGNANCY TEST KIT PREGNANCY TEST URINE JHI AVENTIR BIOTECH, LLC 909312

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other