BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUE COVID-19 TEST CARTRIDGE POUCH/ READER

    MDR report key: 14436381 · Received May 18, 2022

    Report

    Report Number
    MW5109772
    Event Type
    Injury
    Date Received
    May 18, 2022
    Date of Event
    May 13, 2022
    Report Date
    May 16, 2022
    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 EMPLOYER INSTITUTED MANDATORY ASYMPTOMATIC SCREENING USING THE CUE COVID-19 TEST ABOUT A MONTH AGO. MINE IS S/N (B)(4), CARTRIDGE LOT 22704L. OVER MY FIRST 20 TESTS ON THE CUE THE DEVICE FAILED TO DETECT RNASE P CONTROL IN MY SWAB 30% OF THE TIME, AND I GOT A PCR VERIFIED FALSE POSITIVE WITHIN THE FIRST 10 TESTS. I HAVE USED THE TEST ACCORDING TO THE INSTRUCTIONS CAREFULLY. I PREVIOUSLY USED RAPID TESTS (BINAXNOW) DAILY FOR ABOUT TWO MONTHS WITH NO ISSUES. IN THE LAST MONTH, FOUR OTHER PEOPLE HAVE REPORTED FALSE POSITIVES WITH CUE AND TWO PEOPLE HAVE COME TO WORK WITH SYMPTOMATIC COVID AFTER TESTING NEGATIVE BY CUE TESTS A COUPLE OF TIMES. SINCE WE ADOPTED CUE TESTING, WE ARE NO LONGER REQUIRED TO WEAR MASKS AND SOCIAL DISTANCE AT WORK, AS IF THEY THINK THE CUE TESTS ARE GOING TO RELIABLY DETECT ASYMPTOMATIC AND EARLY COVID INFECTIONS DUE TO IRRESPONSIBLE AND INACCURATE MARKETING CLAIMS BY CUE. THE CUE TEST MATERIALS THEMSELVES CONTAIN LEGAL DISCLAIMERS THAT A NEGATIVE TEST FOR AN ASYMPTOMATIC PERSON IS NONINFORMATIVE, AND I THINK MY COMPANY IS PUTTING US AT RISK BY MISINTERPRETING THE VERY SLICK MARKETING MATERIALS FOR CUE. I WENT LOOKING FOR REAL WORLD CUE DATA, ESPECIALLY TECHNICAL SPECIFICATIONS BECAUSE I AM AN ASSAY DEVELOPER AND MOLECULAR SCREENING SCIENTIST. THE DATA SEEMS VERY SPARSE AND HIGHLY CURATED IN THE LITERATURE. MANY OF THE SCIENTISTS IN OUR GROUP ARE CONCERNED THAT THE DEVICE IS BASICALLY A SCAM AND USING IT IS WORSE THAN NOTHING, BUT OUR EMPLOYER WON'T ADMIT THERE IS A PROBLEM OR CHANGE COURSE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2031261 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201 22704L (CARTRIDGE)
    2031262 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2031263 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032377 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032378 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032379 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032380 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032381 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032382 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201
    2032383 CUE COVID-19 TEST CARTRIDGE POUCH/ READER REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH, INC. C0201

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Female Disability