BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 2456891 · Received February 16, 2012

    Report

    Report Number
    1061932-2012-00535
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Date of Event
    January 25, 2012
    Report Date
    January 25, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ON (B)(4) 2012, CUSTOMER REPORTED A BROWNISH LEAK AROUND THE MIXING CHAMBER AREA OF THE DXH 800 HEMATOLOGY SYSTEM. CUSTOMER COULD NOT LOCATE THE SOURCE. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND OBSERVED THAT THE NUCLEATED RED BLOOD CELL (NRBC) DRAIN PORT WAS PLUGGED. FSE CLEANED THE PORT AND VERIFIED DRAINAGE. NO FURTHER LEAKS WERE REPORTED. REPAIRS WERE VERIFIED AS PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS.

    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