BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIV 1/2 STAT-PAK ULTRA FAST

    MDR report key: 335648 · Received May 23, 2001

    Report

    Report Number
    MW1022046
    Event Type
    Malfunction
    Date Received
    May 23, 2001
    Date of Event
    April 1, 2001
    Report Date
    May 8, 2001
    Manufacturer
    CHEMBIO DIAGNOSTIC SYTEMS, INC.
    Product Code
    MWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FALSE NEGATIVE HIV TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23923 HIV 1/2 STAT-PAK ULTRA FAST IMMUNOLOGIC TEST FOR ANTIBODIES TO HIV 1 & 2 MWB CHEMBIO DIAGNOSTIC SYTEMS, INC. HIV 101 HIV 032000/2

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other