BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FASTEP COVID-19 ANTIGEN HOME TEST, (SELF-TEST)

    MDR report key: 18777540 · Received February 23, 2024

    Report

    Report Number
    MW5151909
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    February 12, 2024
    Report Date
    February 12, 2024
    Manufacturer
    AZURE BIOTECH, INC
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I TRIED USING 3 DIFFERENT CASSETTES FROM THE FASTEP COVID-19 ANTIGEN HOME TEST. LOT NUMBER IS I2212113. EXPIRATION DATE IS 12-12-2024. I ORDERED THESE FROM AMAZON, AND HAVE USED THIS BRAND BEFORE. I OBTAINED MY NASAL SWAB AS USUAL AND MIXED WITH THE TEST MEDIUM. I PUT THE INSTRUCTED 3 DROPS INTO THE SPECIMEN WINDOW, AS PER INSTRUCTIONS. AFTER 15+ MINUTES THE LIQUID HAD FAILED TO DISPERSE ACROSS THE TAKE, SO I HAD NO RESULT. THE CONTROL T LINE ALSO WAS NOT REACHED. THEREFORE, I GOT NO RESULT. I HAVE USED THIS BRAND BEFORE, BUT THIS LOT YIELDED NO RESULT AT ALL. I WAS TESTING MYSELF FOR COVID. I AM A FULLY-LICENSED PHYSICIAN, BOARD-CERTIFIED IN INTERNAL MEDICINE AND 2 OTHER SPECIALTIES. REFERENCE REPORTS: MW5151910, MW5151911.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1565554 FASTEP COVID-19 ANTIGEN HOME TEST, (SELF-TEST) CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP AZURE BIOTECH, INC I12212113

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female