BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS EX 10 COLOR 3 LASER FLOW CYTOMETER

    MDR report key: 17911689 · Received October 11, 2023

    Report

    Report Number
    1061932-2023-00106
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    September 18, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BECKMAN COULTER
    Product Code
    OYE
    UDI-DI
    15099590677466
    PMA / PMN Number
    K183592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THE SHEATH HARNESS WAS BROKEN AND THAT THE INTERNAL TANK WAS NOT FILLING AUTOMATICALLY. THE CUSTOMER WAS MANUALLY FILLING THE INTERNAL TANK. THE CUSTOMER TECHNICAL SUPPORT (CTS) ORDERED A SHEATH HARNESS AND SCHEDULED SERVICE. THE FILED SERVICE ENGINEER (FSE) CONFIRMED THAT THE SHEATH HARNESS WAS BROKEN AND THAT INTERNAL SHEATH LEVEL ERRORS WERE GENERATED BY THE SYSTEM. THE FSE ALSO FOUND THAT THE VORTEXER WAS NOT WORKING PROPERLY. THE FSE REPLACED THE SPRING ADJUSTABLE SHEATH HARNESS AND THE MCL LIFTER MOTOR RESOLVE THE ISSUE. BOTH PART FAILURES CAN CONTRIBUTE TO QUESTIONABLE/ERRONEOUS RESULTS. LABELING: PER THE NAVIOS INSTRUCTIONS FOR USE (PN: A96247AE), THE USER IS INSTRUCTED TO AND/OR ADVISED OF: 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. BEC INTERNAL IDENTIFIER - (B)(4).

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED SAMPLES SHOW UNUSUAL PATTERNS ON THE NAVIOS EX 10 COLORS/3 LASER FLOW CYTOMETER DUE TO A BROKEN SHEATH HARNESS. THE RESULTS WERE REJECTED AS QUESTIONABLE/ERRONEOUS DUE TO THE HISTOGRAM PATTERNS. THE CUSTOMER WAS RUNNING A LABORATORY DESIGNED TEST (LDT). THERE WERE QUESTIONABLE PATIENT RESULTS GENERATED BUT NOT REPORTED OUT OF THE LABORATORY. THERE WAS NO ADVERSE EVENT, CHANGE OR EFFECT TO PATIENT TREATMENT IN CONNECTION TO THE EVENT. THE RESULTS WERE REJECTED AS QUESTIONABLE/ERRONEOUS DUE TO THE HISTOGRAM PATTERNS. THE CUSTOMER WAS RUNNING A LABORATORY DESIGNED TEST (LDT). THE DATA PROVIDED BY THE CUSTOMER CONFIRMS THE UNUSUAL HISTOGRAM PATTERNS. THIS PATTERN COULD BE INTERPRETED AS A FALSE NEGATIVE OR GENERATE AN ERRONEOUS VALUE. THE CUSTOMER FOLLOWED LABELING INSTRUCTIONS AND CALLED TO REPORT THE ISSUE. THE POTENTIALLY ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY QUALITY CONTROL WAS WITHIN SPECIFICATIONS. THE ISSUE MANIFESTED AFTER THE QC RUN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164513 NAVIOS EX 10 COLOR 3 LASER FLOW CYTOMETER FLOW CYTOMETRIC REAGENTS AND ACCESSORIES. OYE BECKMAN COULTER TN NAVIOS EX 10 COLORS/3 LASERS 15099590677466

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown