BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IN-HOME HIV TEST ORAQUICK

    MDR report key: 20091242 · Received August 27, 2024

    Report

    Report Number
    MW5158927
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 13, 2024
    Report Date
    August 22, 2024
    Manufacturer
    ORASURE TECHNOLOGIES, INC.
    Product Code
    QSS
    UDI-DI
    00608337103403
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    RECEIVED A FALSE POSITIVE TEST RESULT ON AN ORAQUICK IN-HOME HIV TEST. LOT NUMBER 006711890A. EXPIRATION DATE 2026-01-31. AS FAR AS I AM AWARE I FOLLOWED ALL INSTRUCTIONS PROPERLY. I WANTED TO REPORT THIS JUST TO RECORD IN THE FIELD USE FAULT OF THE PRODUCT, IN CASE THE LOT WAS CONTAMINATED/DAMAGED BEFORE DISTRIBUTION. ALSO REPORTED TO ORAQUICK COMPANY ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493945 IN-HOME HIV TEST ORAQUICK HIV SELF-TESTS QSS ORASURE TECHNOLOGIES, INC. 006711890A 00608337103403

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Male ZYRTEC