BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 HOME TEST KIT FLOWFLEX

    MDR report key: 14632078 · Received June 7, 2022

    Report

    Report Number
    MW5110163
    Event Type
    Malfunction
    Date Received
    June 7, 2022
    Date of Event
    June 4, 2022
    Report Date
    June 5, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE TESTED POSITIVE ON SIX FLOWFLEX COVID RAPID TESTS OVER THE COURSE OF 10 DAYS. IN THAT TIME, I HAVE TESTED NEGATIVE ON ABBOTT BINAX TESTS, IHEALTH TESTS, AND A LAB-ADMINISTERED PCR. I ISOLATED FOR SIX DAYS IN A HOTEL TO PROTECT OTHERS AS A RESULT OF THE INITIAL POSITIVE TESTS. I NOW BELIEVE I WAS NEVER POSITIVE AT ALL. I USED SIX TESTS FROM THREE DIFFERENT BOXES. I STILL HAVE ONE BOX, BUT THE TESTS THEMSELVES ARE GONE. MY WIFE AND SON BOTH USED THESE TESTS EARLIER IN MAY WITHOUT PROBLEMS. MY WIFE WAS NEGATIVE (AND WAS NEGATIVE ON MULTIPLE BRANDS OF TESTS AND A PCR) AND MY SON WAS POSITIVE ON MULTIPLE BRANDS AND A PCR. I BELIEVE THAT I WILL ALWAYS BE POSITIVE ON THIS BRAND OF TESTS. THIS IS THE WHITE BOX, NOT THE RECALLED BLUE BOX. LOT COV@2020024, 2023-02-03, (B)(4). DURATION: 10 DAYS; REASON FOR USE: TEST FOR COVID-19. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323713 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    323714 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2020024
    323715 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    323716 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    323717 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    323718 COVID-19 HOME TEST KIT FLOWFLEX CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male