BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 10873248 · Received November 20, 2020

    Report

    Report Number
    1650733-2020-00010
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    May 7, 2020
    Report Date
    November 2, 2020
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    DURING VALIDATION TESTING, LUMINEX EMPLOYEE REPORTED SEEING FALSE NEGATIVE RESULTS IN THE ARIES SARS-COV-2 ASSAY COMPARED WITH CEPHEID EUA AND SARS-COV-2 LDT (US CDC DESIGN). THERE IS NO ASSOCIATED ADVERSE EVENT. THE DISCREPANT RESULT OCCURRED DURING VALIDATION TESTING AND THERE WAS NO ADVERSE EVENT ASSOCIATED. THERE WAS NO INDICATION OF CONSUMABLE OR DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1344884 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION N/A AB0585A

    Patients

    Seq Age Sex Outcome Treatment
    1