BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12021101 · Received June 17, 2021

    Report

    Report Number
    3002777243-2021-00004
    Event Type
    Malfunction
    Date Received
    June 17, 2021
    Date of Event
    September 30, 2020
    Report Date
    June 15, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSTICS, INC.
    Product Code
    QJR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    ON (B)(6) 2020, LUMINEX MAS REPORTED POSSIBLE CONTAMINATION ON CUSTOMER'S BEHALF. THE CUSTOMER SAW INCONSISTENT RESULTS WITH SERACARE NEGATIVE CONTROL AND SUSPECTED CONTAMINATION. MAS PROVIDED INSTRUCTIONS FOR WIPE TEST. CUSTOMER PERFORMED A CONTAMINATION TEST WHERE THEY ADDED REAGENTS USED IN EXTRACTION, WATER, AND NEGATIVE CONTROL WITH IC, DIRECTLY TO COV WELLS AND RAN THROUGH THE THERMOCYCLER AND MAGPIX. THE FOLLOWING SAMPLES HAD HIGH LEVELS OF BOTH MS2 AND COVID PRESENT FOR ALL TARGETS, MOST LIKELY CONTAMINATED FROM A PATIENT OR SERACARE (AND MS2 FOR THE CRNA) DURING SETUP RECENTLY: C2, NEG WITH IC, D2, CARRIER RNA, E3, NEG WITH IC. ADDITIONALLY THERE WERE ELEVATED SIGNALS FOR THE FOLLOWING TARGETS WHICH COULD BE DUE TO CONTAMINATION OR ALSO SETTING UP AT ROOM TEMPERATURE: A1, WATER, C3, WATER SQUIRT BOTTLE MAGPIX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918629 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSTICS, INC. IK054C-0041, IK054C-0042

    Patients

    Seq Age Sex Outcome Treatment
    1