BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARDETECT COVID-19 ANTIGEN HOME TEST

    MDR report key: 15412530 · Received September 12, 2022

    Report

    Report Number
    MW5111980
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 9, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    GOT 8 MAXIMBIO CLEARDETECT COVID-19 ANTIGEN TESTS FROM USPS. (HAVE USED OTHER TESTS BEFORE.). IN 6 OF THE 8 TESTS TRIED SO FAR, I'VE GOTTEN NO CONTROL LINE OR TEST LINE APPEARING. I'VE REREAD THE INSTRUCTIONS SEVERAL TIMES, AND FOLLOWED THEM TO THE LETTER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746306 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.
    2746307 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.
    2746308 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.
    2746309 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.
    2746310 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.
    2746311 CLEARDETECT COVID-19 ANTIGEN HOME TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male ALLEGRA| ALOGLIPTIN| AMLODIPINE-OLMESARTAN | B COMPLEX WITH C COMPLETE | BUPROPION| CARVEDILOL | D3| DULOXETINE| FAMOTIDINE| FINASTERIDE| IRON| METFORMIN | NIASPAN| SILODOSIN | TRICOR| VALACYCLOVIR| VITAMIN OVER 50 D3