BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1916728 · Received December 7, 2010

    Report

    Report Number
    1061932-2010-00251
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    September 28, 2010
    Report Date
    September 28, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACCOUNT USES TYPE A CASSETTES WITH 4 ML BD TUBES. THE DXH800 INSTRUMENT CONTAINS A DRIP TRAY IN THE MIXER AREA DESIGNED TO CATCH ANY LEAKS. THE LAB PERSONNEL HAVE BEEN NOTIFIED OF THE CASSETTE ISSUE IN AN EFFORT TO PREVENT PATIENTS FROM BEING REDRAWN UNNECESSARILY. A NEW SET OF CASSETTES WERE ORDERED FOR THE CUSTOMER. THE ROOT CAUSE FOR THIS EVENT IS THE EXPANDABLE GRIPPERS (OR CLIPS) IN THE CASSETTE ARE STAYING OPEN, CAUSING THE SAMPLE TUBE TO COME OUT OF THE CASSETTE WHILE THE CASSETTE IS MIXING AND/OR DURING TRANSPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO THE SAMPLE TUBES FALLING FROM UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM CASSETTE. THE TUBES FELL INTO AND WERE CONTAINED IN THE DRIP TRAY DESIGNED TO CATCH ANY LEAKS. THE TUBES WERE IDENTIFIED AS MISSING WHEN CBC TEST ORDERS FOR THREE PATIENT SPECIMENS WERE LISTED AS PENDING AFTER BEING SORTED ON THE AUTOMATION LINE (PRE-ANALYTICAL). THE TUBES WERE FOUND INSIDE THE INSTRUMENT NEAR THE CASSETTE MIXER ASSEMBLY. THE TUBES WERE NOT BROKEN OR DAMAGED. NO REPORTS OF DEATH, INJURY OR AFFECT TO PATIENT TREATMENT AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM HEMATOLOGY ANALYZER GKZ BECKMAN COULTER INC. DXH 800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1