BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMBIO CLEARDETECT COVID TEST

    MDR report key: 15825574 · Received November 17, 2022

    Report

    Report Number
    MW5113346
    Event Type
    Malfunction
    Date Received
    November 17, 2022
    Date of Event
    November 14, 2022
    Report Date
    November 16, 2022
    Manufacturer
    MAXIM BIOMEDICAL 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

    MAXIMBIO CLEARDETECT COVID TESTS DO NOT WORK - NO CONTROL LINES WHEN TESTING ON 4 TESTS. AT LEAST ONE FALSE NEGATIVE ON ADDITIONAL TEST. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1372010 MAXIMBIO CLEARDETECT COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL INC. MB07JUL2201
    1372011 MAXIMBIO CLEARDETECT COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL INC. MB07JUL2201
    1372012 MAXIMBIO CLEARDETECT COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL INC.
    1372013 MAXIMBIO CLEARDETECT COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL INC.
    1372014 MAXIMBIO CLEARDETECT COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female