BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER

    MDR report key: 23241266 · Received October 7, 2025

    Report

    Report Number
    1061932-2025-00029
    Event Type
    Malfunction
    Date Received
    October 7, 2025
    Date of Event
    September 10, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    OYE
    PMA / PMN Number
    K183592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BECKMAN FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND CONFIRMED THE REPORTED ISSUE. THE FSE FOUND THERE WAS A FLOW RATE ISSUE DUE TO CLOGGED TUBING. THE ISSUE WAS RESOLVED THE ISSUE THROUGH ROUTINE TROUBLESHOOTING AND REPLACEMENT OF ALL TUBING RELATE TO THE FLOW CELL WASTE. THE INSTRUMENT WAS VERIFIED AS OPERATING TO SPECIFICATIONS. PER NAVIOS INSTRUCTIONS FOR USE (PN: A96247): O THERE IS A RISK OF REPORTING INCORRECT RESULTS. DATA DISPLAYS USED TO ARRIVE AT THE TEST RESULT FOR LIGHT SCATTER PATTERNS, ANTIBODY STAINING PROFILES, AND ALL GATES AND BOUNDARIES SHOULD BE REVIEWED BY A LABORATORY PROFESSIONAL WHEN INTERPRETING THE DATA. IF RESULTS ARE SUSPECT, FOLLOW YOUR LABORATORY'S PROCEDURES TO RESOLVE. THE USER FOLLOWED THE PUBLISHED INSTRUCTIONS AND DID NOT REPORT THE SUSPICIOUS RESULTS. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SIDE SCATTER SIGNAL IS DROPPING ON THE NAVIOS EX 10 COLOR/3 LASE WHEN RUNNING THEIR LABORATORY DEVELOPED TEST (LDT) PROTOCOL. THE DATA ATTACHED IN THE SERVICE REQUEST SHOWS UNEXPECTED PATTERNS FOR FORWARD (FS) VERSUS SIDE (SS) SCATTER, THE ISSUE COULD POTENTIALLY IMPACT ANY OF THE CD MARKERS RUN IN THE TEST PANEL. THE EVENT OCCURRED WHEN THE CUSTOMER WAS RUNNING THEIR LABORATORY DEVELOPED TEST (LDT) PROTOCOL ON THE NAVIOS EX 10 COLOR/3 LASER FOR LEUKEMIA/LYMPHOMA IMMUNOPHENOTYPING BUT DID NOT SPECIFY WHICH CELL MARKERS WERE INCLUDED IN THE PROTOCOL. THE TEST RUNS WERE REJECTED WERE RE-RUN ON A DIFFERENT NAVIOS WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2609831 NAVIOS FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER, INC. TN NAVIOS EX 10 COLORS/3 LASERS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown