BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY EUA

    MDR report key: 11749870 · Received April 29, 2021

    Report

    Report Number
    1650733-2021-00006
    Event Type
    Malfunction
    Date Received
    April 29, 2021
    Date of Event
    March 17, 2021
    Report Date
    April 29, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY OR DEATH AT THE TIME OF THE DISCREPANT RESULT. THE MDR IS BEING SUBMITTED PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020. BASED ON THE INVESTIGATION COMPLETED, THE DEVICE DID NOT FAIL TO MEET SPECIFICATION. THERE WAS NO INDICATION OF CONSUMABLE OR DEVICE MALFUNCTION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FALSE POSITIVE CORONAVIRUS RESULTS ON SARS COV-2 ASSAY (US EUA-IVD) ON THE ARIES. · ARIES RUN ONE, CASSETTE ID (B)(4), POSITIVE FOR (B)(4), NEGATIVE FOR N GENE. · ARIES RUN TWO, CASSETTE ID (B)(4), NEGATIVE FOR (B)(4) AND NEGATIVE FOR N GENE (RAN FROM THE SAME SWAB AS ARIES RUN ONE). · ARIES RUN THREE, CASSETTE ID, ENDING IN (B)(4), PATIENT SWAB WAS RECOLLECTED AND WAS NEGATIVE. · CONFIRMATION TESTING- HOLOGIC- NEGATIVE FOR CORONAVIRUS. CUSTOMER HAD A PREVIOUS DIAGNOSIS OF CORONAVIRUS. PATIENT WAS GETTING RE-TESTED AS A ROUTINE CHECK UP FOR CO-VID-2 AFTER PREVIOUS DIAGNOSIS OF CORONAVIRUS AFTER 97 DAYS. CUSTOMER ALSO SAID THE CUSTOMER WAS VACCINATED FOR CO-VID BUT WAS NOT ABLE TO CONFIRM WHEN CUSTOMER RECEIVED VACCINATION. THERE WAS NO REPORTED INJURY OR DEATH AT THE TIME OF THE DISCREPANT RESULT. THE MDR IS BEING SUBMITTED PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647185 ARIES SARS-COV-2 ASSAY EUA ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB1608A

    Patients

    Seq Age Sex Outcome Treatment
    1