BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15136394 · Received July 29, 2022

    Report

    Report Number
    3016758165-2022-00103
    Event Type
    Malfunction
    Date Received
    July 29, 2022
    Date of Event
    January 18, 2022
    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 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 A CUSTOMER REPORTED TO A CUE HEALTH INC. TECHNICAL SUPPORT REPRESENTATIVE TWO (2) FALSE POSITIVE RESULTS VIA CUE. THE CUSTOMER FOLLOWED UP WITH A NEGATIVE PCR. CUSTOMER DID NO PROVIDE DETAILS REGARDING THE PCR TEST. CARTRIDGE LN 20857E, CARTRIDGE SN'S (B)(4); READER SN (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829259 CUE COVID-19 TEST FOR HOME AND OVER THE COUNTER (OTC) USE REAGENTS, 2019-NOVEL CORONAVIRUS NUCLEIC ACID QJR CUE HEALTH INC. C2020 20857E

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown