BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 10873114 · Received November 20, 2020

    Report

    Report Number
    1650733-2020-00022
    Event Type
    Malfunction
    Date Received
    November 20, 2020
    Date of Event
    May 21, 2020
    Report Date
    November 9, 2020
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOLECULAR APPLICATIONS SPECIALIST (MAS) HAS REPORTED A NEGATIVE ARIES SARS-COV-2 RESULT WHEN RUNNING IN COMPARISON WITH THEIR CEPHEID SYSTEM WHICH REPORTED A POSITIVE RESULT. THIS PATIENT SAMPLE WAS USED FOR QUALITY CONTROL ON THE ARIES SYSTEM. ARIES: NOT DETECTED CEPHEID: DETECTED RUN RESULTS RECEIVED: 1ST RUN: SPECIMEN 1 CEPHEID CT VALUES E GENE=33.7 N2 GENE=36.5 ARIES CT=ND. SPECIMEN 2 CEPHEID CT VALUES E GENE =30.6 N2 GENE= 33.7 ARIES CT= ND. 2ND RUN: SPECIMEN 1 CEPHEID CT VALUES E GENE=31.4 N2 GENE=34.2 ARIES CT=ND. SPECIMEN 2 CEPHEID CT VALUES E GENE =30.2 N2 GENE= 33.2 ARIES CT= N=37.6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1338047 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1