BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15126919 · Received July 28, 2022

    Report

    Report Number
    3016758165-2022-00097
    Event Type
    Malfunction
    Date Received
    July 28, 2022
    Date of Event
    January 10, 2022
    Report Date
    July 28, 2022
    Manufacturer
    CUE HEALTH INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A TECHNICAL SUPPORT REPRESENTATIVE REVIEWED CUSTOMER DATA AND NOTED THAT THE CUE READER WAS PERFORMING WITHIN SPECIFICATIONS. TO BETTER ADDRESS FALSE POSITIVE TEST RESULTS, THE CUE READER FIRMWARE WAS UPGRADED TO VERSION 0.17.7, RELEASED IN LATE DECEMBER 2021, TO DETECT AND CANCEL THE TEST INSTEAD OF RELEASING FALSE POSITIVE RESULTS.

    Description of Event or Problem · 0

    ON (B)(6) 2022 A DIRECT-TO-CONSUMER (DTC) CUSTOMER REPORTED TO A CUE HEALTH INC. TECHNICAL SUPPORT REPRESENTATIVE A FALSE POSITIVE TEST RESULT FOLLOWED BY TWO NEGATIVE CUE COVID-19 TESTS. ON (B)(6) 2022, CUSTOMER REPORTED TAKING UP A FOLLOW- UP PCR TEST AT STANFORD ON (B)(6) 2022 AND RECEIVED A NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317067 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. CUE COVID-19 TEST CARTRIDGE PACK, HOME & OTC, 10-PK (C2020) 18147H 18273I

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown