BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLOWFLEX ANTIGEN HOME TEST

    MDR report key: 18758704 · Received February 21, 2024

    Report

    Report Number
    MW5151804
    Event Type
    Injury
    Date Received
    February 21, 2024
    Date of Event
    February 13, 2024
    Report Date
    February 18, 2024
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QYT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I TOOK A FLOWFLEX ANTIGEN HOME TEST. IT WAS POSITIVE. I WENT TO THE URGENT CARE AND GOT A PCR (POLYMERASE CHAIN REACTION) RVS. BOTH WERE NEGATIVE. THEY ASKED ME TO DO ANOTHER AT HOME AND I DID AND IT WAS POSITIVE. I DID ANOTHER PCR ON WED. NEG. THURS. BINAXNOW NEG. FRIDAY BINAXNOW NEG. I'M SO GLAD I DID NOT TAKE THE PAXLOVID. I HAVE A BACTERIAL INFECTION. MY BOXES OF FLOWFLEX SAY EXPIRE 2025, DATE (2) (B)(6), ONE (B)(6) ON 1. YOUR WEBSITE SAYS 2024 FOR COV3030007 OV3030007 EXPIRE THIS MONTH. THIS WAS A FALSE POSITIVE I BELIEVE BECAUSE THE CLOSE EXPIRATION DATE BEING 2024 NOT 2025.REFERENCE # MW5151805.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1576219 FLOWFLEX ANTIGEN HOME TEST OVER-THE-COUNTER COVID-19 ANTIGEN TEST QYT ACON LABORATORIES, INC. COV3030009

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other AMLODIPINE.| BINAXNOW COVID TEST.| CALCIUM .| COQ10 .| LIPITOR "MYBECK".| MAGNESIUM.| POTASSIUM .| RESTASIS.| VITAMIN C .| VITAMIN D2.