BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 12019838 · Received June 17, 2021

    Report

    Report Number
    1650733-2021-00010
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    May 27, 2021
    Report Date
    June 17, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 A FALSE POSITIVE ON A PATIENT SAMPLE WHILE USING ARIES SARS-COV2- EUA ASSAY. ARIES INITIAL TESTING SARS-COV2 POSITIVE (THE SPECIMEN WAS NPS IN UTM. POSITIVE FOR ORF1AB GENE (ORF GENE DETECTED AT 19.8). CUSTOMER CONFIRMED THAT THEIR WAS NO FREEZE/THAW CYCLE WITH THE ARIES, THE RESULTS WERE RAN RIGHT AWAY ON THE ARIES). ARIES REPEAT TESTING WAS NOT PERFORMED. CONFIRMATION TESTING PERFORMED ON HOLOGIC PANTHER- NOT DETECTED FOR SARS-COV2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918548 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB2141A

    Patients

    Seq Age Sex Outcome Treatment
    1