BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15135972 · Received July 29, 2022

    Report

    Report Number
    3016758165-2022-00100
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    December 24, 2021
    Report Date
    July 29, 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) 2021, A DIRECT-TO-CONSUMER (DTC) CUSTOMER REPORTED TO A CUE HEALTH INC. TECHNICAL SUPPORT REPRESENTATIVE ONE POSITIVE RESULT, FOLLOWED BY TWO NEGATIVE RESULTS. ASYMPTOMATIC, AND THE REST OF THE FAMILY TESTED NEGATIVE. ALL TESTS CONDUCTED WITH CUE. CARTRIDGE LN 19732L; CARTRIDGE SN (B)(4); READER SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829247 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 19732L

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown