BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14138557 · Received April 18, 2022

    Report

    Report Number
    1650733-2022-00018
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 22, 2022
    Report Date
    April 18, 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 00043 (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 · 0

    THE CUSTOMER CALLED IN REPORTING A FALSE POSITIVE PATIENT SAMPLE WHEN RUNNING THE SARS-COV-2 ASSAY ON ARIES S/N (B)(4). RUN 1: PERFORMED OR ARIES (MODULE A): POSITIVE RESULT. RUN 2: PERFORMED ON CEPHEID GENEXPERT: NEGATIVE RESULT. RUN 3: PERFORMED ON ARIES (MODULE B): NEGATIVE RESULT. THERE WAS NO AN ALTERATION TO PATIENT THERAPY, SERIOUS INJURY, OR DEATH BEEN ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186080 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION AB5320A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown