BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15782461 · Received November 11, 2022

    Report

    Report Number
    3016758165-2022-00293
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Report Date
    November 11, 2022
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA210180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXPLANATION FOR H3: CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, THE DEVICES COULD NOT BE EVALUATED. INVESTIGATION WAS NOT ABLE TO BE PERFORMED. CUSTOMER DID NOT PROVIDE CARTRIDGE SERIAL NUMBERS AND DID NOT RESPOND TO THREE ATTEMPTS FROM TECHNICAL SUPPORT FOR ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    CUSTOMER CONTACTED CUE HEALTH, INC. CUSTOMER SUCCESS MANAGER TO REPORT TEAM MEMBERS WITH SYMPTOMS TESTING NEGATIVE ON THE CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE BUT POSITIVE ON PCR (BRAND UNSPECIFIED). CUSTOMER DID NOT PROVIDE EXACT FREQUENCY OF FALSE NEGATIVE RESULTS, NUMBER OF INDIVIDUALS INVOLVED, DATES OF OCCURRENCE OR CARTRIDGE SERIAL NUMBERS. ALTHOUGH REQUESTED, NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2830568 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown