BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12318837 · Received August 13, 2021

    Report

    Report Number
    3002777243-2021-00013
    Event Type
    Malfunction
    Date Received
    August 13, 2021
    Date of Event
    July 6, 2021
    Report Date
    August 13, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    ON (B)(6) 2021, THE CUSTOMER REPORTED DISCREPANT RESULTS FOR TWO SAMPLES. THE SAMPLES WERE TESTED USING MULTIPLE ASSAYS. CEPHEID ASSAY REPORTED TWO SAMPLES (B)(6) BASED ON N2 GENE DETECTION. NXTAG COV EXTENDED PANEL REPORTED SAMPLES AS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1216356 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSTICS, INC. IK054C-0053

    Patients

    Seq Age Sex Outcome Treatment
    1