BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2

    MDR report key: 12274373 · Received August 4, 2021

    Report

    Report Number
    3002777243-2021-00012
    Event Type
    Malfunction
    Date Received
    August 4, 2021
    Date of Event
    June 30, 2021
    Report Date
    August 3, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QLT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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

    THE CUSTOMER REPORTED THAT THEY HAVE A SAMPLE WHICH GENERATED AN INVALID RESULT, AND UPON REPEAT FROM EXTRACTION, IT GENERATED 7 POS CALLS (INCLUDING FLU A AND FLU B). THE THIRD REPEAT FROM A NEW EXTRACTION GENERATED AN INVALID RESULT. THE SAMPLE IN QUESTION WAS RUN ON AN ALTERNATE ASSAY (GENMARK) AND IT GENERATED A NEG CALL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1175162 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 NXTAG RESPIRATORY PATHOGEN PANEL + SARS-COV-2 QLT LUMINEX MOLECULAR DIAGNOSTICS, INC. IK056C-0003

    Patients

    Seq Age Sex Outcome Treatment
    1