BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17694188 · Received September 6, 2023

    Report

    Report Number
    3016758165-2023-00803
    Event Type
    Malfunction
    Date Received
    September 6, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 6, 2023
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    PMA / PMN Number
    EUA210180
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESPONSE TO H3 DEVICE EVALUATED BY MANUFACTURER: CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, THE DEVICES COULD NOT BE EVALUATED. INVESTIGATION COULD NOT BE COMPLETED DUE TO LACK OF INFORMATION. LOT NUMBER, READER SERIAL NUMBER OR CARTRIDGE SERIAL NUMBER WERE NOT PROVIDED.

    Description of Event or Problem · 0

    CUSTOMER RECEIVED TWO POTENTIAL FALSE POSITIVE RESULTS ON (B)(6) 2023 USING THE CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE (CARTRIDGE SN, LOT NUMBER AND READER SN NOT PROVIDED). CUSTOMER TESTED NEGATIVE WITH A COVID-19 ANTIGEN TEST ON (B)(6) 2023 (BRAND OF ANTIGEN TEST NOT PROVIDED). CUSTOMER REPORTED HAVING A COVID-19 INFECTION PRIOR TO THIS TESTING EVENT. PRIOR TO RECEIVING THE POTENTIAL FALSE POSITIVE RESULTS, THE CUSTOMER OBTAINED THE FOLLOWING TEST RESULTS (NOT QUESTIONING THESE RESULTS): (B)(6) 2023: CUE COVID-19 TEST = POSITIVE RESULT 2X. (B)(6) 2023: UNSPECIFIED COVID-19 ANTIGEN TEST = POSITIVE RESULT 1X. (B)(6) 2023: UNSPECIFIED COVID-19 ANTIGEN TEST = NEGATIVE RESULT. (B)(6) 2023: UNSPECIFIED COVID-19 ANTIGEN TEST = NEGATIVE RESULT. (B)(6) 2023: UNSPECIFIED COVID-19 ANTIGEN TEST = NEGATIVE RESULT (B)(6) 2023: CUE COVID-19 TEST = NEGATIVE RESULT. (B)(6) 2023: CUE COVID-19 TEST = NEGATIVE RESULT. (B)(6) 2023: CUE COVID-19 TEST = NEGATIVE RESULT. ALTHOUGH REQUESTED, CUSTOMER DID NOT RESPOND TO TECHNICAL SUPPORTS THREE ATTEMPTS TO OBTAIN FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1831391 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown