BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID19 TEST

    MDR report key: 10436135 · Received August 20, 2020

    Report

    Report Number
    MW5096160
    Event Type
    Malfunction
    Date Received
    August 20, 2020
    Date of Event
    July 1, 2020
    Report Date
    August 18, 2020
    Manufacturer
    LUSYS LABORATORIES, INC.
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LUSYS LABORATORIES, LOCATED IN (B)(4) , THE COMPANY IS SELLING TEST THAT GIVES FALSE NEGATIVE, I HAD 4 PATIENTS ALL PCR POSITIVE, WHEN WE APPLY LUSYS LAB TEST THE RESULT WERE NEGATIVE AFTER 2 WEEKS AFTER POSITIVE RESULT WITH PCR. LUSYS LABORATORIES REPRESENTS A DANGER TO OUR SOCIETY. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899529 COVID19 TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO LUSYS LABORATORIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Other