BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 25176515 · Received May 14, 2026

    Report

    Report Number
    2531491-2026-00122
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 26, 2026
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    PMA / PMN Number
    EUA210494
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE CURRENT COMPLAINT IS PENDING INVESTIGATION FROM ACON'S CONTRACT MANUFACTURER. ACON WILL SUBMIT A FOLLOW-UP MDR UPON INVESTIGATION COMPLETION. ANY ADDITIONAL INFORMATION RECEIVED BY ACON MAY BE INCLUDED WITH A FOLLOW-UP MDR.

    Description of Event or Problem · 0

    INVALID RESULT(S): CUSTOMER PURCHASED 3 FLOWFLEX KITS, WHICH ALL PRODUCED INVALID RESULTS. NO C LINE APPEARED. HE FOLLOWED THE DIRECTIONS EXACTLY AND WAITED 15 MINUTES. THE SAMPLE WAS DISPENSED INTO THE S WELL. THE T LINE APPEARED IMMEDIATELY AND AFTER 15 MINUTES, NO C LINES APPEARED AT ALL. HE HAS SINCE THROWN THE TEST CASSETTES AWAY AND CANNOT PROVIDE PICTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415223 FLOWFLEX COVID-19 ANTIGEN HOME TEST ANTIGEN DIAGNOSTIC FOR SARS-COV-2 QKP ACON LABORATORIES, INC. COV5038003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown