BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 14976373 · Received July 8, 2022

    Report

    Report Number
    MW5110769
    Event Type
    Malfunction
    Date Received
    July 8, 2022
    Date of Event
    July 6, 2022
    Report Date
    July 6, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD BEEN TESTING WITH A PCR TEST EACH WEEK THROUGH THE LAST WEEK OF MAY WITH A NEGATIVE TEST EVERY TIME. I THEN SWITCHED TO HOME ANTIGEN TESTING WITH THE FLOWFLEX COVID-19 ANTIGEN HOME TEST ON JUNE 3RD THROUGH JULY 6TH. WITH THE FLOWFLEX TEST, I TESTED ONE OR TWICE A WEEK IN THIS TIME PERIOD. THE TEST WOULD RESULT IN A PINK LINE FOR THE "C" EACH TIME AND A VERY LIGHT TO FAINT LINE WITH THE "T". I HAD NO SYMPTOMS BEFORE I STARTED USING THIS TEST OF DURING THIS TIME PERIOD. TODAY, I USED THE FLOWFLEX TEST AND THE CLINITEST RAPID COVID-19 ANTIGEN SELF-TEST TODAY. I HAD THE SAME RESULT WITH A FAINT PINK LINE FOR THE "T" BUT THE CLINITEST WAS CLEARLY NEGATIVE. I HAVE HAD NO SYMPTOMS OF COVID DURING THIS TIME PERIOD AND DO NOT HAVE ANY NOW. I WEAR A MASK AT WORK AND TRY TO DISTANCE AND ONLY HAD A COVID EXPOSURE 4 DAYS AGO WHICH WAS IN A VERY LOW RISK SETTING. I AM USING NASACORT AND ASTELIN NASAL SPRAY AND WONDER IF IT INTERFERED WITH THE FLOWFLEX TEST OR IF THE TEST IS NOT WORKING CORRECTLY. PINK LINE FOR THE C AND FAINT PINK LINE FOR THE T. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396145 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. REF L031-118B5
    2396146 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. REF L031-118B5 COV1110217

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female ASTELIN NASAL SPRAY| NASACORT NASAL SPRAY