BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUE COVID-19 TEST KIT

    MDR report key: 19720971 · Received July 10, 2024

    Report

    Report Number
    MW5157188
    Event Type
    Injury
    Date Received
    July 10, 2024
    Date of Event
    March 25, 2024
    Report Date
    July 7, 2024
    Manufacturer
    CUE HEALTH, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY LONG COVID SYMPTOMS HAD FINALLY STARTED TO ABATE AFTER TWO YEARS AND I CONTINUED TO QUARANTINE MOST OF THE TIME AS A WAY OF LIFE. EVERY FEW WEEKS, I TRIED TO PCR TEST TO CATCH ASYMPTOMATIC SARS COVID-19 INFECTIONS. SINCE I WAS CAREFUL TO USE HEALTH AND SAFETY PROTOCOLS, I FELT DEVASTATED TO RECEIVE A POSITIVE COVID PCR RESULT FROM CUE ON (B)(6) 2024. I LET MY DOCTOR KNOW AND HE PRESCRIBED PAXLOVID - WHICH WAS HARD TO FIND BECAUSE PFIZER PULLED IT OFF THE PHARMACY SHELVES FOR REBRANDING. THIS WAS STRESSFUL AND SCARY. I THEN RECEIVED NEGATIVE LABPCR NAATS ON (B)(6) 2024 AS WELL AS A NEGATIVE METRIX NAAT ON (B)(6) 2024 AND NEGATIVE CUE NAAT AND METRIX NAAT AND RAPID ANTIGEN TEST ON (B)(6) 2024. AFTER THE POSITIVE CUE TEST ON (B)(6) 2024 FOLLOWED BY FIVE NEGATIVE PCR TESTS AND A NEGATIVE RAPID ANTIGEN TEST AND LEARNING THAT CUE WAS PULLED FROM THE MARKET, I BELIEVE THE (B)(6) 2024 CUE TEST RESULT WAS A FALSE POSITIVE. READER SN (SERIAL NUMBER): (B)(6). CARTRIDGE SN (SERIAL NUMBER): (B)(6). TEST ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2385359 CUE COVID-19 TEST KIT REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. 31033G

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Disability