BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER

    MDR report key: 2924523 · Received January 22, 2013

    Report

    Report Number
    1061932-2013-00106
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE WAS NOT DISPATCHED AS THE CUSTOMER RESOLVED THE ISSUE TROUBLESHOOTING. THE CUSTOMER MIXED AND REPLACED THE DIFFERENTIAL SCATTER PAK AND RESOLVED THE DIFFERENTIAL ISSUES. THE INSTRUMENT WAS IN NORMAL OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED ELEVATED LYMPHOCYTE (LY) RESULT AND LOW NEUTROPHIL (NE) RESULT, FOR ONE PATIENT, INVOLVING THE COULTER HMX HEMATOLOGY ANALYZER WITH AUTOLOADER. THE PATIENT SAMPLE PRODUCED AN INITIAL LYMPHOCYTE RESULT OF 75% AND NEUTROPHIL RESULT 23%. THE MANUAL DIFFERENTIAL ANALYSIS RECOVERED LOWER LYMPHOCYTE RESULT OF 5% AND A HIGHER NEUTROPHIL RESULT OF 83%, WHICH WERE CONSIDERED CORRECT AND REPORTED TO THE HOSPITAL. THE ERRONEOUS RESULTS WERE NOT RELEASED OUT OF THE LABORATORY. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30489 COULTER® HMX HEMATOLOGY ANALYZER WITH AUTOLOADER COUNTER, DIFFERENTIAL CELL GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1