BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XN-10

    MDR report key: 8283610 · Received January 28, 2019

    Report

    Report Number
    1000515253-2019-00004
    Event Type
    Injury
    Date Received
    January 28, 2019
    Date of Event
    December 29, 2018
    Report Date
    January 28, 2019
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    GKZ
    UDI-DI
    04987562424214
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSMEX XN-2000 INSTRUCTION FOR USE (IFU), CHAPTER 11 - CHECKING DETAILED ANALYSIS INFORMATION (DATA BROWSER), SECTION 11.6 - IP MESSAGES, DETAILS THE METHOD IN WHICH THE ANALYZER CONVEYS ITS FINDINGS. RESULTS WITHOUT AN ERROR MESSAGES ARE CLASSIFIED INTO POSITIVE/NEGATIVE BASED ON THE PRESET CRITERIA. THE SYSTEM BASES ITS JUDGMENTS ON COMPREHENSIVE SURVEYS OF NUMERICAL DATA, PARTICLE SIZE DISTRIBUTIONS, SCATTERGRAMS, AND PROVIDES EASILY-TO-UNDERSTAND FLAGS/MESSAGES INDICATING THE INSTRUMENTS FINDINGS. THESE FLAGS/MESSAGES ARE REFERRED TO AS "IP (INTERPRETIVE PROGRAM) MESSAGES." THE OPERATOR IS CAUTIONED: A "POSITIVE" OR "ERROR" JUDGMENT INDICATES THE POSSIBILITY OF AN ABNORMALITY. IF A "POSITIVE" OR "ERROR" JUDGMENT OCCURS, CHECK THE DATA AND REPEAT THE TEST OR EXAMINE CAREFULLY IN ACCORDANCE WITH THE PROTOCOL OF YOUR LABORATORY." THE SYSMEX XN-2000 IFU, CHAPTER 15 - TECHNICAL INFORMATION, NORMAL REFERENCE INTERVAL STATES THE NORMAL REFERENCE RANGE FOR PLT FOR FEMALES IS 182-369 X 10^3/UL. THE USER ERRONEOUSLY RELEASED THE RESULTS PRIOR TO ADDITIONAL VERIFICATION.

    Description of Event or Problem · 1

    THE SAMPLE WAS ANALYZED GENERATING A DECREASED IMPEDANCE PLATELET (PLT-I) COUNT OF 43 X 10^3/UL. THE SAMPLE WAS REANALYZED THE SAME DAY FOR A FLUORESCENCE PLT ( PLT-F) AND GENERATED A PLT-F ZERO VALUE. THE USER REPORTED A PLT RESULT OF LESS THAN 4 X 10^3/UL TO THE LABORATORY INFORMATION SYSTEM (LIS). A PERIPHERAL SMEAR WAS PREPARED AND THE PLT ESTIMATE WAS REPORTED AS "DECREASED". THE PATIENT WAS TRANSFUSED ONE UNIT OF PLATELETS BASED ON THE REPORTED RESULTS. A NEW BLOOD SAMPLE WAS COLLECTED AND ANALYZED POST TRANSFUSION, GENERATING A PLT COUNT OF 72 X 10^3/UL. REPEAT ANALYSIS FOR PLT-F GENERATED A ZERO VALUE. A SLIDE WAS PREPARED AND THE PLT ESTIMATE DID NOT AGREE WITH THE PLT-F RESULT. THE SAMPLE WAS REPEATED TWO MORE TIMES FOR PLT ANALYSIS, GENERATING PLT RESULTS OF 69 X 10^3/UL AND 71 X 10^3/UL. THE USER REPORTED A PLT RESULT OF 69 X 10^3/UL AND A PLT ESTIMATE OF "DECREASED" TO THE LIS. A CORRECTED REPORT WAS ISSUED FOR THE INITIAL SAMPLE TO CHANGE THE PLT RESULT FROM A VALUE OF < 4 X 10^3/UL TO A PLT VALUE OF 43 X 10^3/UL. THERE WAS NO KNOWN NEGATIVE IMPACT FROM THE TRANSFUSION FOR THE INVOLVED PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73784 XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION, I SQUARE XN-10 04987562424214

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other