BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUE HEALTH COVID TEST

    MDR report key: 19370773 · Received May 21, 2024

    Report

    Report Number
    MW5155181
    Event Type
    Injury
    Date Received
    May 21, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 17, 2024
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I HAD FULL COVID SYMPTOMS BUT THE CUE TEST TURNS OUT NEGATIVE, WHILE A RAPID TEST SHOWED SLIGHT POSITIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1559124 CUE HEALTH COVID TEST REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown