BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMBIO CLEAR DETECT COVID 19 TEST

    MDR report key: 15282596 · Received August 23, 2022

    Report

    Report Number
    MW5111658
    Event Type
    Malfunction
    Date Received
    August 23, 2022
    Date of Event
    August 20, 2022
    Report Date
    August 20, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAVE USED A NUMBER OF DIFFERENT AT HOME COVID TESTS WITHOUT ANY ISSUE. THE USG RECENTLY SHIPPED OUT MAXIMBIO TESTS. I FOLLOWED THE INSTRUCTIONS TO THE LETTER. AND GOT NO RESPONSE. NOT A NEGATIVE. NOT A POSITIVE. I THOUGHT IT WAS AN ANOMALY SO I USED THE SECOND TEST. AGAIN, NO RESPONSE. THERE IS SOMETHING WRONG WITH THESE TESTS. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202815 MAXIMBIO CLEAR DETECT COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB27JUNN2201
    1202816 MAXIMBIO CLEAR DETECT COVID 19 TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. 95677 MB27JUNN2201

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female