BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARIES SARS-COV-2 ASSAY

    MDR report key: 11866190 · Received May 21, 2021

    Report

    Report Number
    1650733-2021-00007
    Event Type
    Malfunction
    Date Received
    May 21, 2021
    Date of Event
    May 5, 2021
    Report Date
    May 21, 2021
    Manufacturer
    LUMINEX CORPORATION
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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

    (B)(6) 2021 CUSTOMER REPORTED VIA EMAIL THE OCCURRENCE OF A FALSE POSITIVE RESULT ON ARIES SARS-COV2-EUA ASSAY PN: 50-10047, LOT: AB2010A. THE SAMPLE ANALYSIS SHOWED POSITIVE ON THE ORF1AB GENE TARGET WITH A CT VALUE OF 26.0. THERE WAS NO N GENE TARGET DETECTED. PER THE ARIES SARS-COV-2 PACKAGE INSERT, A POSITIVE RESULT WILL OCCUR IF BOTH OR EITHER OF THE ORF1AB GENE OR THE N GENE TARGETS INDICATE POSITIVE. SAMPLE WAS REPEATED ON ARIES AND CONFIRMATION TESTING PERFORMED. BOTH CONFIRMATION TEST AND ARIES REPEAT RESULTED AS NEGATIVE. THE CUSTOMER VERIFIED THE ARIES RESULT WAS NOT REPORTED OUT TO A PHYSICIAN, THEREFORE, THERE WERE NO ADVERSE EVENTS ASSOCIATED OR CHANGE IN THERAPY AS THE RESULT. THE SPECIMEN WAS NPS IN PHOSPHATE-BUFFERED SALINE, WHICH IS INCONSISTENT WITH THE ARIES SARS-COV2 EUA PACKAGE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761148 ARIES SARS-COV-2 ASSAY ARIES SARS-COV-2 ASSAY QJR LUMINEX CORPORATION AB2010A

    Patients

    Seq Age Sex Outcome Treatment
    1