BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 EUA

    MDR report key: 14149152 · Received April 19, 2022

    Report

    Report Number
    1650733-2022-00016
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    February 6, 2022
    Report Date
    April 19, 2022
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    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 SITE CALLED IN REPORTING 8 FALSE NEGATIVE RESULTS ON ARIES SARS-COV2-EUA ASSAY PN: 50-10047, LOT: AB5143A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1186087 ARIES SARS-COV-2 EUA ARIES SARS-COV-2 EUA QJR LUMINEX CORPORATION 50-10047 AB5143A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown