BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVIOS FLOW CYTOMETER SYSTEM

    MDR report key: 4306640 · Received December 8, 2014

    Report

    Report Number
    1061932-2014-02990
    Event Type
    Malfunction
    Date Received
    December 8, 2014
    Date of Event
    November 14, 2014
    Report Date
    November 14, 2014
    Manufacturer
    BECKMAN COULTER IRELAND INC.
    Product Code
    OYE
    PMA / PMN Number
    K130373
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON REVISION OF THE MANUFACTURER IT WAS CHANGED FROM BECKMAN COULTER BREA, CALIFORNIA TO BECKMAN COULTER MIAMI, FLORIDA.

    Additional Manufacturer Narrative · 1

    AN INTERNAL REVIEW REVEALED THAT THE LEGAL MANUFACTURER INFORMATION SUBMITTED IN THE INITIAL REPORT (AND A SUBSEQUENT FOLLOW-UP #1) WAS INCORRECT; THE CORRECTED INFORMATION IS PROVIDED IN THIS FOLLOW-UP REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND REPORTED THAT THE FORWARD SCATTER (FS) SIGNAL DROPPED FROM CHANNEL 750 TO CHANNEL 540 OVER A PERIOD ON ONE MONTH. THE FSE REPORTED THAT THE SIDE SCATTER (SS) AND ALL THE FLUORESCENCES WERE RELATIVELY STABLE DURING THIS TIME. THE FSE ADJUSTED THE ALIGNMENT OF THE ARGON LASER USING THE PICO MOTOR ADJUSTMENT RESOLVING THE PROBLEM. ANY ISSUES WOULD BE APPARENT TO THE OPERATOR WHEN RUNNING FLOW CHECK PRO BEADS AND CONTROLS. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN APPROXIMATE 200 CHANNEL DROP IN FORWARD SCATTER (FS) SIGNAL OVER A ONE MONTH PERIOD OF TIME ON FLOW CHECK PRO BEADS WHEN USING THE NAVIOS FLOW CYTOMETER. DURING THIS TIME THE CUSTOMER WAS COMPENSATING FOR THE DRIFT BY ADJUSTING THE FS VOLTAGE AND LYMPHOCYTE GATE. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE ANALYZER. THERE WERE NO ERRONEOUS TEST RESULTS ASSOCIATED WITH THIS EVENT. THERE WAS NO DEATH, INJURY OR AFFECT TO USER OR PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790987 NAVIOS FLOW CYTOMETER SYSTEM AUTOMATED DIFFERENTIAL CELL COUNTER OYE BECKMAN COULTER IRELAND INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1