BEUDAMED
    FDA Adverse Event Death Summary report: N

    MONOBIND, INC.

    MDR report key: 887573 · Received July 24, 2007

    Report

    Report Number
    MW5003191
    Event Type
    Death
    Date Received
    July 24, 2007
    Date of Event
    July 24, 2005
    Report Date
    July 24, 2007
    Manufacturer
    MONOBIND INC.
    Product Code
    LOM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THERE ARE SOME HEPATITIS AND HIV1/2 KITS IN THE MARKET BY THE NAME OF MONOBIND INC, WHICH HAS BEING SOLD SINCE 2005 TILL NOW IN THE MIDDLE EAST. THE EXTERNAL LABEL OF THE BOX CONFIRMS, "FOR IN VITRO DIAGNOSTICS USE ONLY". THE QUALITY OF KITS HAVE BEEN QUALIFIED AND EVALUATED BY DIFFERENT CLINICAL LABORATORIES, AND ALL OF THOSE LABS CONFIRM THE QUALITY OF KITS ARE TERRIBLE, AND THERE ARE A LOT OF FALSE NEGATIVE RESULTS FOR HIV1/2 AND HEPATITIS. THEREFORE, YOU ARE ASKED TO MAKE AN INVESTIGATION OF THIS VERY CRITICAL MATTER WITH MONOBIND, BECAUSE THIS ISSUE HAS ALREADY EFFECTED A LOT OF POOR PTS' HEALTH AND LIVES. DATES OF USE: IT IS MORE THAN 2 YEARS. 2005-2007. DIAGNOSIS: HIV1/2 AND HEPATITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MONOBIND, INC. ACCUBIND ELISA 96 DETERMINATIONS LOM MONOBIND INC. EIA-61K2F1
    2 MONOBIND INC. ACCUBIND ELISA 96 DETERMINATIONS MZF MONOBIND INC. EIA-67K2F1

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Congenital Anomaly| D| L| O| R| S