BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST

    MDR report key: 15760298 · Received November 8, 2022

    Report

    Report Number
    MW5113166
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 7, 2022
    Manufacturer
    MAXIMBIO / MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED NUMEROUS COVID-19 AT-HOME TEST KITS FROM USPS (THANK YOU FOR SUPPLYING TESTS AS A PUBLIC HEALTH MEASURE!) FROM MAXIMBIO. UNFORTUNATELY, ALL OF THEIR TESTS DO NOT WORK; THE CONTROL LINE DOES NOT EVEN APPEAR. I HAVE USED MANY TESTS. I HAVE A PHD. I AM USING THEM ACCORDING TO THEIR DIRECTIONS CORRECTLY. THEY DO NOT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2946844 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIMBIO / MAXIM BIOMEDICAL, INC. 221298

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female