BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16645181 · Received March 30, 2023

    Report

    Report Number
    3016758165-2022-00070
    Event Type
    Malfunction
    Date Received
    March 30, 2023
    Date of Event
    December 23, 2021
    Report Date
    March 30, 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

    INVESTIGATION CONCLUSION: RESPONSE TO DEVICE EVALUATED BY MANUFACTURER: CARTRIDGES USED BY THE CONSUMER WERE NOT SENT BACK FOR EVALUATION, THEREFORE, THE DEVICES COULD NOT BE EVALUATED. THE CUSTOMER PROVIDED INFORMATION REGARDING THE SUSPECTED FALSE POSITIVE TEST AND A MEMBER OF THE TECHNICAL SUPPORT GROUP WAS ABLE TO PERFORM DATA ANALYSIS. THE COMPLAINT HISTORY WAS REVIEWED AND THERE WAS ONE PREVIOUS SIMILAR COMPLAINT AGAINST INVOLVED LOT. THE LOT HISTORY RECORD (LHR) WAS REVIEWED FOR THE LOT NUMBER IN THE COMPLAINT, AND IT PASSED RELEASE SPECIFICATIONS. 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) 2021, A DIRECT-TO-CONSUMER CUSTOMER REPORTED TO A CUE HEALTH INC TECHNICAL SUPPORT REPRESENTATIVE A FALSE POSITIVE RESULT WITH NO SYMPTOMS; SUBSEQUENT CUE TESTS WERE NEGATIVE. CARTRIDGE LOT: 19895E; CARTRIDGE SN: (B)(4); READER SN: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566433 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC C2020 19895E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown