BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE

    MDR report key: 15268874 · Received August 22, 2022

    Report

    Report Number
    3016758165-2022-00110
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    March 14, 2022
    Report Date
    August 22, 2022
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK TO CUE HEALTH INC., THEREFORE, OUR TECH OPS TEAM COULD NOT EVALUATE THE DEVICES. A TECHNICAL SUPPORT REPRESENTATIVE REVIEWED CUSTOMER DATA AND PERFORMED DATA ANALYSIS. ALL DATA VALUES WERE NORMAL AND MET ACCEPTABLE CRITERIA. ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 0

    ON (B)(6) 2022, A CUSTOMER WAS POSITIVE ON CUE FOLLOWED BY A NEGATIVE CUE RESULT ON THE SAME DAY. ON THE SAME DAY, CUSTOMER TOOK A NASAL PCR TEST AND GOT A NEGATIVE RESULT. THE NEXT DAY, ON (B)(6) 2022 CUSTOMER WENT TO A DOCTOR AND GOT A NEGATIVE COVID RESULT. CUSTOMER ALSO GOT NEGATIVE RESULTS ON THE LUCERA AND BINAXNOW ANTIGEN TESTS. CUSTOMER WAS SYMPTOMATIC (STUFFY NOSE AND SORE THROAT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256195 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 21622J

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown