BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 11995466 · Received June 14, 2021

    Report

    Report Number
    1650733-2021-00009
    Event Type
    Malfunction
    Date Received
    June 14, 2021
    Date of Event
    May 25, 2021
    Report Date
    June 2, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    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

    THE CUSTOMER CALLED IN REPORTING A FALSE NEGATIVE WHEN RUNNING THE SARS-COV-2 ASSAY EUA ASSAY ON ARIES S/N (B)(4). ARIES RUN ONE- NEGATIVE FOR SARS COV-2 EUA, NEGATIVE FOR THE ORF1AB GENE AND NEGATIVE FOR N GENE. ARIES RUN TWO- THERE WAS NO RERUN ON THE ARIES. CONFIRMATION TESTING- GENE XPERT AND BIOFIRE- DETECTED FOR SARS COV-2. GENE XPERT- CT-33.2 S, TM- NOT AVAILABLE. THE ARIES RESULTS WERE REPORTED TO THE MEDICAL TEAM. THE LAB DOES NOT KNOW IF THERE WAS ANY CHANGE IN THERAPY OR ADVERSE EVENT TO THE PATIENT BASED ON ARIES RESULTS. THE LAB DID SAY THAT THE MEDICAL TEAM KNOWS THAT THE PATIENT HAD CO-VID AND IS A PLACED IN A SPECIAL UNIT FOR CO-VID PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893020 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB1787A

    Patients

    Seq Age Sex Outcome Treatment
    1