BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 16103008 · Received January 4, 2023

    Report

    Report Number
    MW5114158
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    January 2, 2023
    Report Date
    January 2, 2023
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TWO DIFFERENT MAKERS TESTS WERE. TAKEN AT THE SAME TIME I TESTED POSITIVE ON QUICKVUE AT HOME OTC COVID-19'S TESTS AND NEGATIVE ON FLOFLEX. WE WERE LOW SO MY SON WENT TO CVS AND HAD TO BUY A PACKAGE OF 12 FLOFLEX KITS AS CVS DID NOT GIVE THEM AWAY. AT THE SAME TIME I TESTED NEGATIVE WITH FLOWFLEX AND I TESTED POSITIVE WITH QUICKVUE IN ALL TESTS THE C LINE SHOWED UP. FLOFLEX INFORMATION REF- L031-118B5, LOT. COV2020151 2003-09-22 ON THE 12 PACK BOX AND INDIVIDUAL BOXES. ALSO ON INDIVIDUAL BOXES IT SAYS NEW EXP DATE. DISREGARD EXP DATE PRINTED ON POUCH. EXP 2023-02-23 ON PACKET/POCKET INSIDE EXP 2203-08-09 ON EXTRACTION BUFFER TUBE SEAL ALSO ON INDIVIDUAL BOX L0313201. COVID-19 SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122433 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP ACON LABORATORIES, INC. COV2020151

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Other B12| CYMBALTA| D3| ELAVIL | FLEXERIL| NORCO AS NEEDED| SOMETIMES BENADRYL| VALSARTAN-HYDROCHLOROTHIAZIDE