BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOWFLEX COVID-19 ANTIGEN HOME TEST

    MDR report key: 14521943 · Received May 26, 2022

    Report

    Report Number
    MW5109948
    Event Type
    Malfunction
    Date Received
    May 26, 2022
    Date of Event
    May 24, 2022
    Report Date
    May 24, 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

    THE TUBE CONTAINING THE RE-AGENT FOR THE FLOWFLEX COVID-19 ANTIGEN HOME TEST WAS EMPTY. IT CONTAINED NO FLUID. THE TUBE APPEARED TO BE PROPERLY SEALED FROM THE FACTORY (AND STILL IS SEALED, IF NEEDED). PRODUCT WAS SHIPPED IN A DEFECTIVE STATE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2160746 FLOWFLEX COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. QKP ACON LABORATORIES, INC. COV2010002

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male