BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVCLEAR COVID TEST

    MDR report key: 13618726 · Received February 25, 2022

    Report

    Report Number
    MW5107737
    Event Type
    Malfunction
    Date Received
    February 25, 2022
    Date of Event
    February 15, 2022
    Report Date
    February 23, 2022
    Manufacturer
    EMPOWERED DIAGNOSTICS LLC
    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

    FALSE POSITIVE RESULT; GOT A POSITIVE ANTIGEN TEST WITH COVCLEAR ON (B)(6) 2022 AT 11PM. RETESTED WITH BINAXNOW, NEGATIVE; ON (B)(6) MORNING NEGATIVE BINAXNOW, EVENING QUICKVUE NEGATIVE. ON (B)(6) 2022 PCR SAMPLE TAKEN, RESULT NEGATIVE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298086 COVCLEAR COVID TEST CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM QKP EMPOWERED DIAGNOSTICS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Unknown Other