BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER SYSTEM

    MDR report key: 11609424 · Received April 2, 2021

    Report

    Report Number
    1061932-2021-00046
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 9, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BECKMAN COULTER IRELAND
    Product Code
    OYE
    UDI-DI
    15099590515522
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED BY THE CUSTOMER. THE FIELD APPLICATIONS SPECIALIST (FAS) ASSISTED THE CUSTOMER IN RUNNING THE AUTO SETUP PROTOCOL TO CREATE NEW COMPENSATION SETTINGS AS PER NORMAL WORK FLOW IN THE INSTRUCTIONS FOR USE. THE FAS FOUND THERE WERE NO COMPENSATION SETTINGS IN THE TETRA PROTOCOL. THE FIELD APPLICATIONS SPECIALIST (FAS) ASSISTED THE CUSTOMER IN RUNNING THE AUTO SETUP PROTOCOL TO CREATE NEW COMPENSATION SETTINGS. THERE WAS NO MALFUNCTION OF THE INSTRUMENT IDENTIFIED. BEC INTERNAL IDENTIFIER: (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TETRACXP PATIENT PANEL RESULTS ALL POSITIONED IN QUADRANT 2 ON THEIR NAVIOS FLOW CYTOMETER. ERRONEOUS PATIENT RESULTS MAY HAVE BEEN GENERATED BUT WERE DISCARDED DUE TO CONTROL FAILURE. THERE WAS NO REPORTED DEATH, INJURY OR CHANGE TO PATIENT TREATMENT. THE CUSTOMER RUNS THE AUTO SETUP ONCE A WEEK AND USES THE SAME SETTINGS TO RUN SAMPLE CONTROLS AND PATIENT SAMPLES FOR THE WEEK. THE SAMPLE CONTROL FAILED. THE CUSTOMER DISCARDED THE RUN DATA AND DID NOT REPORT ANY PATIENT RESULTS. THE SAMPLES WERE RE-RUN ON A SECOND INSTRUMENT WITH NO ISSUE. EXAMPLE DATA WAS REQUESTED FROM THE CUSTOMER BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506803 NAVIOS FLOW CYTOMETER SYSTEM FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER IRELAND TN,NAVIOS 10 COLORS/3 LASERS 15099590515522

    Patients

    Seq Age Sex Outcome Treatment
    1