BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2409674 · Received January 11, 2012

    Report

    Report Number
    1061932-2012-00034
    Event Type
    Malfunction
    Date Received
    January 11, 2012
    Date of Event
    December 17, 2011
    Report Date
    December 17, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BECKMAN COULTER IDENTIFIER FOR THIS REPORT IS (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011 CUSTOMER REPORTED A FLUID LEAK, OF APPROXIMATELY 5CC OF BLOODY LIQUID, IN THE DXH 800 INSTRUMENT AND ON THE TOPS OF THE TUBES. CUSTOMER FOUND TUBING DISCONNECTED AT THE PROBE WIPE AND RESOLVED THE PROBLEM BY RECONNECTING THE TUBE. NO ONSITE SERVICE WAS REQUIRED AS THE INSTRUMENT WAS RUNNING WITHIN SPECIFICATIONS. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. DXH 800

    Patients

    Seq Age Sex Outcome Treatment
    1