BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COVID-19 ANTIBODY COMPREHENSIVE TEST

    MDR report key: 16103040 · Received January 4, 2023

    Report

    Report Number
    MW5114159
    Event Type
    Malfunction
    Date Received
    January 4, 2023
    Date of Event
    December 13, 2022
    Report Date
    December 31, 2022
    Manufacturer
    UNK
    Product Code
    QKO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NH, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WE HAVE THREE MEMBERS IN OUR HOUSEHOLD (ONE OF WHOM IS NOT BIOLOGICALLY RELATED) WHO COULD NOT OBTAIN ENOUGH BLOOD TO PROVIDE A SAMPLE SUFFICIENT FOR TESTING DESPITE EXPLICITLY FOLLOWING ALL DIRECTIONS. WE CALLED THE COMPANY (4U HEALTH); THE CO-FOUNDER, "(B)(6)," INSTRUCTED US TO RUN OUR HANDS UNDER WARM WATER AND ASSURED US THAT THIS REMEDY WORKED "99% OF THE TIME." ALL THREE OF US MADE A SUBSEQUENT ATTEMPT FOLLOWING THIS ADDITIONAL INSTRUCTION AND STILL COULD NOT OBTAIN A SUFFICIENT SAMPLE. WE HAVE LEFT MULTIPLE MESSAGES FOR THE COMPANY SINCE THEN AND HAVE NOT RECEIVED A CALL BACK. WE BELIEVE THIS PRODUCT IS NOT USER-FRIENDLY TO THE AVERAGE PERSON AND SHOULD NOT BE MARKETED TO THE GENERAL PUBLIC.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED ON 01/11/2022 FOR REPORT MW5114159 TO UPDATE PROCODE TO QKO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122434 COVID-19 ANTIBODY COMPREHENSIVE TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO UNK
    1258662 COVID-19 ANTIBODY COMPREHENSIVE TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO UNK
    1258663 COVID-19 ANTIBODY COMPREHENSIVE TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO UNK
    1258664 COVID-19 ANTIBODY COMPREHENSIVE TEST REAGENT, CORONAVIRUS SEROLOGICAL QKO UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male ALFUZOSIN| AMOXICILLIN| ASPIRIN | ATORVASTATIN | CENTRUM SILVER| PLAVIX