BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM

    MDR report key: 4112852 · Received September 24, 2014

    Report

    Report Number
    1061932-2014-02427
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    BECKMAN COULTER
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON 08/28/2014, A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) EVALUATED THE SYSTEM AND FOUND THE NRBC (NUCELATED RED BLOOD CELL) MIX CHAMBER WITH THE AMTC (AIR MIX TEMPERATURE CONTROL) AND DV (DISTRIBUTION VALVE) SAMPLE LINES CLOGGED. THE FSE REPLACED THE NRBC MIX CHAMBER AND THE AMTC AND DV SAMPLE LINES RESOLVING THE HIGH NRBC BACKGROUND COUNTS.(B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BACKGROUND COUNT FAILURES OCCURRED FOR THE NRBC (NUCLEATED RED BLOOD CELL) PARAMETER WHEN USING THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER'S FACILITY TO EVALUATE THE SYSTEM. THERE WERE NO ERRONEOUS TEST RESULTS 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
    595585 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1