BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12652306 · Received October 18, 2021

    Report

    Report Number
    3002777243-2021-00014
    Event Type
    Malfunction
    Date Received
    October 18, 2021
    Date of Event
    August 10, 2021
    Report Date
    October 18, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IN REVIEW OF ALL CASE DETAILS AGAINST THE CRITERIA SET FORTH IN DOCUMENT 00043 (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 · 0

    REGULATORY AFFAIRS WAS NOTIFIED THAT THE CASE TRIGGERED A PRE ALERT ON (B)(6). AT THAT TIME, IT WAS UNCLEAR IN TECHNICAL SUPPORT (TS) WHETHER IT WAS AN ASSAY ISSUE OR AN INSTRUMENT ISSUE. ON (B)(6), TS AND REGULATORY AFFAIRS (RA) HAD A MEETING AND DETERMINED THAT THE CASE IS NOT RELATED TO THE ASSAY AND THAT THE INSTRUMENT REQUIRED A ROUTINE MAINTENANCE. PER THE CASE DETAILS, THE CUSTOMER ASKED FOR HARDWARE CLEANING ADVISE FOR THE MAGPIX. THE SUF RECEIVED AND ERROR FOUND - DEVICE ERROR OCCURRED. 2100","800C9580. TS SENT INSTRUCTIONS TO PERFORM A STRINGENT CLEANING AND THEN TO RUN A SMALL TEST TO CONFIRM RESULTS. CUSTOMER CONFIRMED IT WAS RUNNING AS EXPECTED AND ALL MFIS WERE WITHIN RANGE. UPDATE: 8 OCT/2021 - TECHNICAL SUPPORT RECEIVED THE RUN FILES FROM THE CUSTOMER TO PERFORM A DATA REVIEW. RECEIPT OF FILES WAS DELAYED DUE TO AN ISSUE AT CUSTOMER'S END. AFTER DATA REVIEW TS SUGGESTED TO CUSTOMER TO RE-EXTRACT SAMPLES FROM THE PROBLEMATIC BATCH AND THEN RUN AGAIN WITH NEW REAGENTS. CUSTOMER CLEANED THE INSTRUMENT, RE-EXTRACTED SAMPLES USING NEW MS2 AND ALL RESULTS LOOKED GOOD. THIS SUGGESTED IT WAS A ONE TIME EXTRACTION FAILURE. CUSTOMER CONFIRMED ALL ISSUES HAVE BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1550506 NXTAG COV EXTENDED PANEL NXTAG COV QJR LUMINEX MOLECULAR DIAGNOSTICS, INC. IK054C-0056

    Patients

    Seq Age Sex Outcome Treatment
    1