BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COULTER HMX HEMATOLOGY ANALYZER

    MDR report key: 2253217 · Received September 9, 2011

    Report

    Report Number
    1061932-2011-01379
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    April 10, 2009
    Report Date
    April 10, 2009
    Manufacturer
    BECKMAN COULTER, INC.
    Product Code
    GKZ
    PMA / PMN Number
    K010765
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD¿L REPORTABLE EVENTS. THIS MDR IS FOR PT 1 OF 1 ON ANALYZER 2 OF 2. SEE MDR # 1061932-2011-01378 FOR PT 1 OF 1 ON ANALYZER 2. THIS APPEARED TO BE A SAMPLE SPECIFIC ISSUE WHERE NRBCS (NUCLEATED RED BLOOD CELLS) WERE NOTED TO BE AS LARGE AS LYMPHOCYTES. PER BECKMAN COULTER INC LABELING, NRBCS ARE A KNOWN INTERFERING SUBSTANCE FOR WHITE BLOOD CELL COUNTS AND VERY SMALL OR MULTI-POPULATION LYMPHOCYTES CAN INTERFERE WITH NRBC IDENTIFICATION. RAW DATA FROM TESTING ON THE HMX ANALYZER WERE NOT PROVIDED FOR ANALYSIS. FIELD SERVICE WAS NOT DISPATCHED FOR THIS EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE HMX HEMATOLOGY ANALYZER DID NOT FLAG FOR NRBC (NUCLEATED RED BLOOD CELLS) OR CORRECT THE WBC (WHITE BLOOD CELL) COUNT ON ONE PT SAMPLE. THE SAMPLE WAS RUN ON THE HMX ANALYZER AND HAS A WBC COUNT TO 45.0 X 10^3. THE TEST RESULTS WERE ACCOMPANIED BY INSTRUMENT-GENERATED MESSAGES. A MANUAL DIFFERENTIAL WAS PERFORMED ON THE SAMPLE. THIRTY NRBCS WERE COUNTED AND THE WBC COUNT WAS ESTIMATED TO BE 30 X 10^3. THE CUSTOMER NOTED THAT SOME NUCLEATED RED BLOOD CELLS WERE AS LARGE AS SMALL LYMPHOCYTES. THE ERRONEOUS TEST RESULTS WERE NOT REPORTED OUT OF THE LAB. THERE WERE NO REPORTED CHANGES TO PT TREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COULTER HMX HEMATOLOGY ANALYZER GKZ BECKMAN COULTER, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR