BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14092026 · Received April 13, 2022

    Report

    Report Number
    1650733-2022-00015
    Event Type
    Malfunction
    Date Received
    April 13, 2022
    Date of Event
    February 23, 2022
    Report Date
    April 12, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    ON (B)(6) 2022, THE CUSTOMER REPORTED TO MAS THAT THEY HAD SEEN FALSE POSITIVE WITH SARS-COV2 EUA WITH A HIGH CT VALUE N GENE. NO ALTERATION TO PATIENT THERAPY, SERIOUS INJURY, OR DEATH ASSOCIATED WITH THIS EVENT BECAUSE THE CUSTOMER IS REPEATING ALL POSITIVES OVER 35 CT ON THE ARIES AND THEN ALSO ON THE PANTHER IN TRIPLICATE. ARIES RUN 1 SARS-COV-2 POSITIVE. ARIES RUN 2 SARS-COV-2 NEGATIVE. PANTHER RUN: NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186063 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5339A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown