BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 11866273 · Received May 21, 2021

    Report

    Report Number
    1650733-2021-00008
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 21, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT (B)(4) (MEDICAL DEVICE REPORTING STANDARD OPERATING PROCEDURE) AND ITS APPLICABLE APPENDICES, THIS COMPLAINT DOES NOT MEET THE REQUIREMENTS FOR AN MDR IN THE COUNTRIES WHERE THE DEVICE IS SOLD OR DISTRIBUTED. HOWEVER, THE MDR IS BEING SUBMITTED TO US FDA PURSUANT TO THE OBLIGATIONS OF THE EMERGENCY USE AUTHORIZATION, AND PER COMMUNICATION RECEIVED FROM FDA ON OCTOBER 7, 2020.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE POSITIVE CORONAVIRUS RESULT WHILE UTILIZING THE SARS-COV-2 ASSAY. THERE WAS NO CONFIRMATION TESTING DONE. - ARIES SAMPLE ONE RESULT: SARS-COV2 POSITIVE. - ARIES SAMPLE ONE REPEAT: SARS-COV2 NEGATIVE. THE ARIES RESULTS WERE REPORTED TO THE MEDICAL TEAM BUT THERE WAS NO ADVERSE EVENTS OR CHANGE IN THERAPY ASSOCIATED WITH THIS REPORTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761149 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB2010A

    Patients

    Seq Age Sex Outcome Treatment
    1