BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXH 800 COULTER® CELLULAR ANALYSIS SYSTEM

    MDR report key: 2882613 · Received December 20, 2012

    Report

    Report Number
    1061932-2012-02847
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    November 20, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    GKZ
    PMA / PMN Number
    K081930
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) VISITED THE SITE AND EXAMINED THE SYSTEM. THE FSE FOUND THAT THE SYSTEM HAD POOR FLOW CELL PHASE ALIGNMENT. THE FSE PERFORMED A FLOW CELL PHASE ALIGNMENT WHICH RESOLVED THE ISSUE. SERVICE WAS VERIFIED FOLLOWING ESTABLISHED PROCEDURES AND THE INSTRUMENT CONFORMS TO PUBLISHED SPECIFICATIONS. THIS IS ONE OF TWO INDIVIDUAL MEDWATCH REPORTS BEING SUBMITTED AS TWO SEPARATE DEVICES WERE INVOLVED. REFERENCE MEDWATCH NUMBERS 1061932-2012-02847 AND 106-1932-2012-02848 FOR ALL ASSOCIATED REPORTS. THE SAME PATIENT SAMPLE IS INVOLVED IN EACH REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BEC) REPORTING THAT ERRONEOUS HIGH NE (NEUTROPHIL) AND LOW MO (MONOCYTE) RESULTS WERE GENERATED BY THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM WITHOUT INSTRUMENT GENERATED FLAGS WHEN COMPARED TO THE PREVIOUS DAY'S INSTRUMENT RESULTS AND MANUAL SMEAR RESULTS FOR A SINGLE PATIENT. THE RESULT WAS REPORTED OUT OF THE LABORATORY. THE DOCTOR QUESTIONED THE RESULTS AND THE SAMPLE WAS RE-RUN ON THE SAME INSTRUMENT AND CORRECT RESULTS WERE OBTAINED. THE SAME SAMPLE WAS ALSO RETESTED ON A SECOND DXH800 INSTRUMENT WHICH GENERATED SIMILAR ERRONEOUS HIGH NE AND LOW MO RESULTS FOR THE FIRST RUN THEN SUBSEQUENTLY CORRECT RESULTS UPON REPEAT. THERE WERE NO INJURIES OR CHANGES TO THE PATIENTS CARE OR TREATMENT. A BECKMAN COULTER FIELD SERVICE ENGINEER WAS DISPATCHED TO THE SITE TO EVALUATE THE SYSTEM.

    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. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR