BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2283511 · Received October 7, 2011

    Report

    Report Number
    1061932-2011-01677
    Event Type
    Malfunction
    Date Received
    October 7, 2011
    Date of Event
    September 11, 2011
    Report Date
    September 11, 2011
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SPECIMEN WAS COLLECTED IN A 3ML BD VACUTAINER TUBE AND WAS FRESH WHEN PROCESSED ON THE INSTRUMENT. THE CONTROLS WERE RUN BEFORE THE EVENT, AND THE INSTRUMENT IS CURRENTLY PERFORMING WITHIN QC SPECIFICATIONS. RAW DATA WAS REQUESTED BUT NOT PROVIDED FOR THE INVESTIGATION. SERVICE WAS DISPATCHED FOR TROUBLESHOOTING AND REPAIR. AN INSTRUMENT VERIFICATION PROCEDURE (IVP) WAS PERFORMED AND FLUIDICS, SOLENOID, VOLTAGE, PRESSURE, VACUUM, AND MIXING CHAMBER WERE VERIFIED. THE FIELD SERVICE ENGINEER (FSE) FOUND VL242 (DIFF MIXING SOLENOID) WAS NOT FUNCTIONING PROPERLY, AND EXCHANGED WITH ANOTHER SOLENOID TO CONFIRM VL242 WAS DEFECTIVE. THE FSE PERFORMED MAINTENANCE CLEANING PROCEDURE. THE FSE IDENTIFIED ASPIRATION PROBE WAS DEFORMED AND REMEDIED. THE FSE PERFORMED SHUTDOWN AND DAILY CHECKS, WHICH PRODUCED ACCEPTABLE RESULTS. LATRON CP-X AND 6C CONTROLS ANALYZED WITH ACCEPTABLE RESULTS. AT COMPLETION OF THE SERVICE CALL THE UNIT WAS LEFT OPERATIONAL. MANIFOLD 201 AND ASPIRATION PROBE ARE SUBJECT FOR REPLACEMENT. ROOT CAUSE IS ATTRIBUTED TO VL242 WHICH WAS NOT FUNCTIONING AND WAS CONFIRMED AS DEFECTIVE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BECKMAN COULTER, INC. (BEC) THAT UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM GENERATED ERRONEOUS WHITE BLOOD CELL (WBC), NEUTROPHIL AND LYMPHOCYTE DIFFERENTIAL RESULTS. THE INSTRUMENT GENERATED "VARIANT LY" SUSPECT MESSAGE AND "HIGH EVENT RATE: D" SYSTEM MESSAGE FOR THE DIFFERENTIAL PARAMETERS. ALL DIFFERENTIAL PARAMETERS (% AND #) WERE ALSO FLAGGED "R." THE INSTRUMENT REPORTED A HIGH LYMPHOCYTE PERCENTAGE, WHICH WAS DETERMINED TO BE NEUTROPHILIC BY BLOOD SMEAR EVALUATION. MANUAL DIFFERENTIAL RESULTS WERE REQUESTED BUT NOT PROVIDED. THE SPECIMEN WAS REPEATED ON AN ALTERNATE INSTRUMENT (COULTER LH HEMATOLOGY ANALYZER) AND PRODUCED A HIGHER WBC VALUE AND NO DIFFERENTIAL RESULTS (NON-NUMERIC) WITH AN INSTRUMENT GENERATED PC2 FLAG. THE ERRONEOUS RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE CORRECT WBC AND DIFFERENTIAL RESULTS REPORTED FOR THIS PATIENT WERE REQUESTED, BUT NOT PROVIDED. THE PATIENT RESULTS PROVIDED BY THE CUSTOMER ARE SHOWN IN THE ATTACHED FILE. THERE WAS NO DEATH, INJURY OR IMPACT TO PATIENT TREATMENT.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1