BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 18364543 · Received December 19, 2023

    Report

    Report Number
    MW5149393
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    December 15, 2023
    Report Date
    December 15, 2023
    Manufacturer
    ACON LABORATORIES, INC
    Product Code
    QKP
    UDI-DI
    00682607660261
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TESTED USING A COVID-19 ANTIGEN TEST FROM ACON LABORATORIES, INC., SAN DIEGO, CA 92121. THE TEST GAVE A FALSE NEGATIVE AS COMPARED TO A SECOND ANTIGEN TEST. I AM STRONGLY POSITIVE BY BINAX NOW AND PCR TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289345 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC COV3090005 00682607660261

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male