BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARDETECT COVID-19 ANTIGEN TEST

    MDR report key: 15241062 · Received August 16, 2022

    Report

    Report Number
    MW5111498
    Event Type
    Malfunction
    Date Received
    August 16, 2022
    Date of Event
    August 14, 2022
    Report Date
    August 14, 2022
    Manufacturer
    MAXIM BIOMEDICAL, INC.
    Product Code
    QKP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TWO FAULTY AT-HOME COVID TESTS. NO RESULTS FROM TWO TEST STRIPS. TWO TEST STRIPS GAVE NO RESULT. LOT#K0420, REF#87506. FDA SAFETY REPORT ID# (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2486983 CLEARDETECT COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. K0420
    2486984 CLEARDETECT COVID-19 ANTIGEN TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP MAXIM BIOMEDICAL, INC. K0420

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male