BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 1951748 · Received January 6, 2011

    Report

    Report Number
    1061932-2011-00014
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 2, 2010
    Report Date
    December 2, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PER AN INTERNAL INVESTIGATION, THE ROOT CAUSE IS ATTRIBUTED TO THE EXPANDABLE GRIPPERS (OR CLIPS) IN THE CASSETTE WHICH BECOME STUCK IN THE OPEN POSITION ALLOWING THE TUBES TO FALL OUT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT SAMPLE TUBES INTERMITTENTLY FALL FROM THE UNICEL DXH CASSETTE OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WHEN THE CLIP THAT USUALLY HOLDS THE TUBE GETS CAUGHT. THE TUBES FALL INTO THE DRIP TRAY OF THE MIXER AREA THAT IS DESIGNED TO CATCH ANY LEAKS. THERE WAS NO EXPOSURE OR REPORTS OF DEATH, INJURY OR CHANGE TO PATIENT TREATMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1