BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12001612 · Received June 15, 2021

    Report

    Report Number
    3002777243-2021-00009
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    August 26, 2020
    Report Date
    June 15, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSITICS
    Product Code
    QJR
    Product Problem
    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER IS REPORTING DISCREPANT RESULTS/FALSE POSITIVES. IT WAS EVIDENT THAT THE SAMPLES THAT WERE DISCREPANT ARE VERY LOW TITERED AND AT LIMIT OF DETECTION (LOD). THEIR POSITIVE CONTROL IS AT A CONCENTRATION THAT IS RIGHT AT THE LOD. THEREFORE, THERE IS A DIFFERENCE IN THE SIGNAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902204 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSITICS IK054C-0038

    Patients

    Seq Age Sex Outcome Treatment
    1