BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUE READER

    MDR report key: 14356881 · Received May 10, 2022

    Report

    Report Number
    MW5109612
    Event Type
    Injury
    Date Received
    May 10, 2022
    Date of Event
    April 21, 2022
    Report Date
    May 6, 2022
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A FALSE POSITIVE COVID TEST USING THE CUE MOLECULAR TEST. THE TEST WAS FOLLOWED UP WITH A HOLOGIC APTIMA LAB TEST THAT WAS NEGATIVE AND 4 SERIAL BINAXNOW AND IHEALTH RAPID TESTS OVER TWO DAYS, PLUS ADDITIONAL NEGATIVE CUE TEST. I HAD PREVIOUSLY PARTICIPATED IN DAILY ASYMPTOMATIC SCREENING WITH THE BINAXNOW TEST OVER THE FIRST OMICRON SURGE AND HAS NOT HAD A FALSE POSITIVE IN 40 TESTS. MY EMPLOYER RECENTLY IMPLEMENTED CUE TESTING AT WORK AND WITHIN THE FIRST 10 TESTS I HAD 4 CANCELED/INVALID RESULTS AND A FALSE POSITIVE. AT LEAST 3 OTHERS REPORTED FALSE POSITIVES AND ONE SYMPTOMATIC FALSE NEGATIVE CONFIRMED BY PCR IN A GROUP OF ABOUT 10 OTHER WORKERS I TALKED TO. I EXPERIENCED FEAR AND INABILITY TO WORK OR CARE FOR MY FAMILY AS A RESULT OF THE FALSE POSITIVE. I BECAME CONCERNED WITH THE LACK OF PERFORMANCE OF THE TESTS DUE TO DISCREPANCIES IN THE CONTROL FAILURE RATES AND SPURIOUS RESULTS COMPARED TO PUBLISHED DATA, BUT WAS SHUT DOWN BY MY EMPLOYERS EH&S LEAD WHEN I ASKED TO TALK TO SOMEONE IN CHARGE ABOUT IT. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1790955 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790956 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790957 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790958 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790959 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790960 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.
    1790961 CUE READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Other| S