BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN HOME TEST

    MDR report key: 20798256 · Received November 27, 2024

    Report

    Report Number
    3014862351-2024-00014
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    November 7, 2023
    Report Date
    November 27, 2024
    Manufacturer
    AZURE BIOTECH, INC.
    Product Code
    QYT
    UDI-DI
    00810022630358
    PMA / PMN Number
    EUA220191
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER CONTACTED FOR A REFUND/ REPLACEMENT AND ADDITIONAL INFORMATION THROUGH AMAZON, BUT NO RESPONSE WAS PROVIDED.

    Description of Event or Problem · 0

    CUSTOMER PURCHASED THE FASTEP TESTS AND KEPT GETTING NEGATIVE RESULTS EVEN THOUGH THE LAB HAD ALREADY CONFIRMED A POSITIVE RESULT. DECIDED TO USE ANOTHER BRAND AND THE RESULTS FOR THOSE WERE POSITIVE AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2368472 FASTEP COVID-19 ANTIGEN HOME TEST COVID-19 ANTIGEN HOME TEST QYT AZURE BIOTECH, INC. I2301009 00810022630358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose