BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX ANTIGEN HOME TEST

    MDR report key: 14521881 · Received May 26, 2022

    Report

    Report Number
    MW5109947
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 23, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    BOTTOMLINE: REPORTING TWO FALSE POSITIVES OF ACON FLOWFLEX ANTIGEN HOME TEST (IN WHITE BOX) ON (B)(6) 2022 ON THE MORNING OF (B)(6) 2022, I ADMINISTERED MY WEEKLY COVID-19 RAPID TEST (ACON FLOWFLEX ANTIGEN HOME TEST) AND TESTED POSITIVE. I'VE TAKEN THIS TEST NEAR-WEEKLY FOR 10-12 WEEKS AND ALWAYS TESTED NEGATIVE. IMMEDIATELY FOLLOWING MY FLOWFLEX POSITIVE ON 2022, I ADMINISTERED AN ABBOTT BINAXNOW COVID-19 TEST, WHICH CAME BACK NEGATIVE. NOW CONCERNED THAT THE TESTS MAY BE SHOWING DIFFERENT RESULTS, I TESTED WITH A SECOND FLOWFLEX (AGAIN, WHITE BOX), WHICH PRODUCED A FAINT POSITIVE. AT THIS POINT, I SCHEDULED A PCR AT (B)(6) AND RECEIVED IT ALSO ON THE MORNING OF (B)(6) 2022 (2-3 HOURS AFTER MY SERIES OF AT-HOME TESTS). ON THE MORNING OF (B)(6) 2022, I AGAIN TESTED WITH THE BINAXNOW, WHICH SHOWED NEGATIVE. WHEN MY PCR RESULTS WERE RETURNED TO ME THIS MORNING ((B)(6) 2022), THEY WERE ALSO NEGATIVE. I'M REPORTING THIS AS I KNOW THERE IS A KNOWN ISSUE (PER THE FDA) WITH ACON FLOWFLEX SARS-COV-2 ANTIGEN RAPID TEST (BLUE BOX), AND SHOULD THERE ALSO BE A CRITICAL MASS OF FALSE POSITIVES WITH THEIR OTHER TEST - WANTED TO AT LEAST ADD TO THAT AWARENESS. THANK YOU FOR YOUR TIME. PHOTO SHOWS TESTS IN ORDER. THE TWO FLOWFLEX TESTS ARE #1 (STILL SHOWS POSITIVE LINE) AND #3 (NO LONGER SHOWING FAINT POSITIVE, BUT IT WAS THERE). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160744 FLOWFLEX ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC.
    2160745 FLOWFLEX ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. NO LONGER HAVE BOX, BUT SEE QR NO LONGER HAVE BOX, BUT SEE QR

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female CHONDROITIN COLLAGEN ATHLETIC GREENS| VITAMIN C AND D GLUCOSAMINE