BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15267346 · Received August 22, 2022

    Report

    Report Number
    3016758165-2022-00109
    Event Type
    Malfunction
    Date Received
    August 22, 2022
    Date of Event
    March 11, 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 FOR EVALUATION, THEREFORE, CUE HEALTH INC. 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 (CARTRIDGE SN (B)(4), LOT #:21806H AND READER SN (B)(4)), CUSTOMER EXPERIENCED A POTENTIAL FALSE POSITIVE. ON THE SAME DAY, CUSTOMER RECEIVED 3 SUBSEQUENT NEGATIVE TEST RESULTS. ON (B)(6) 2022, CUSTOMER TESTED NEGATIVE. CUSTOMER HAD NO SYMPTOMS AND CARTRIDGES WERE STORED AT THE RIGHT TEMPERATURE. OTHER COVID-19 TESTING WAS NOT CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169223 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 21806H

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown