BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12021093 · Received June 17, 2021

    Report

    Report Number
    3002777243-2021-00011
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    December 17, 2020
    Report Date
    June 15, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO REPORTED INJURY OR DEATH AT THE TIME OF THIS REPORT. THE MDR IS BEING SUBMITTED UNDER DEVIATION (B)(4). 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 REPORTING HIGH RATE OF INVALIDS (DUE TO LOW MS2, LOW BEAD COUNTS) AND A HIGH POSITIVITY RATE FOR SARS-COV-2 (>70% FOR MULTIPLE RUNS). ON (B)(6) 2020: CUSTOMER PROVIDED DATA THAT SPANNED TIME BETWEEN (B)(6) AND (B)(6) 2020. THE MAJORITY OF THE INVALID CALLS WERE DUE TO MS2 FAILURES, WITH ANOTHER SUBSET OF INVALIDS RESULTING FROM LOW BEAD COUNTS OR MAGPIX DEVICE ERRORS. ON 12/20/2020: TECHNICAL SUPPORT COMPILED THE DATA THAT CUSTOMER SENT INTO A SPREADSHEET TO OUTLINE ALL INVALID SAMPLES. TECHNICAL SUPPORT REACHED OUT TO CUSTOMER TO SEE IF THEY HAD ANY MORE RECENT DATA TO SHARE, AFTER SEPTEMBER AND AFTER THE EXTRACTION TROUBLESHOOTING WAS PERFORMED. TECHNICAL SUPPORT ALSO REQUESTED THE SUF FOR REVIEW. ON 02/09/2021: TECHNICAL SUPPORT FOLLOWED WITH CUSTOMER TWICE FOR ADDITIONAL DATA. NO RESPONSE FROM CUSTOMER, CASE TO BE CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918628 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSTICS, INC. IK054C-0042

    Patients

    Seq Age Sex Outcome Treatment
    1