BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NXTAG COV EXTENDED PANEL

    MDR report key: 12001625 · Received June 15, 2021

    Report

    Report Number
    3002777243-2021-00006
    Event Type
    Malfunction
    Date Received
    June 15, 2021
    Date of Event
    February 8, 2021
    Report Date
    June 15, 2021
    Manufacturer
    LUMINEX MOLECULAR DIAGNOSITICS
    Product Code
    QJR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    003

    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 INCONSISTENT RESULTS BETWEEN KIT LOTS. TECHNICAL SUPPORT (TS) REVIEWED RAW DATA AND FOUND: MULTIPLE DISCREPANT CALLS, HIGH BACKGROUND, VARIABLE BETWEEN THE SAMPLES, NO NEGATIVE CONTROLS (NTC) WERE BEING RUN. THIS WAS DISCUSSED WITH MOLECULAR APPLICATIONS SPECIALIST (MAS) AND IT WAS SUGGESTED TO RUN SAMPLES IN ORDER BELOW: NTC, NEGATIVE EXTRACTION CONTROL (NEC), POSITIVE CONTROL, NTC, NEC, NTC, NEC, NTC AND ADVISED TO SWITCH OVER TO DRIVE FLUID PLUS. CUSTOMER SENT SUPPORT UTILITY FILES (SUF) FOR BOTH MAGPIX UNITS AND A PREVIOUS RUN WITH NTC AND NEC WHICH WERE CLEAN. THIS WAS ALSO RUN USING THE NEW KIT IN QUESTION. IT WAS CONCLUDED THAT KIT ISSUES CAN BE RULED OUT. TS REVIEWED THE SUF FOR BOTH UNITS AND FOUND CHAMBERS WERE CLEAN. NO MAJOR ERRORS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    902205 NXTAG COV EXTENDED PANEL NXTAG COV EXTENDED PANEL QJR LUMINEX MOLECULAR DIAGNOSITICS IK054C-0054

    Patients

    Seq Age Sex Outcome Treatment
    1