BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XN-10

    MDR report key: 5540403 · Received April 1, 2016

    Report

    Report Number
    1000515253-2016-00010
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    February 26, 2016
    Report Date
    March 4, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATED INFORMATION: THE SITE OWNS 3 XN-10 ANALYZERS AND THE COMPLAINT WAS ORIGINALLY FILED AGAINST THE WRONG XN-10 SERIAL NUMBER. THE XN-10 ANALYZER SERIAL NUMBER (B)(4) GENERATED THE INCORRECT RESULT AND WAS EVALUATED BY REVIEW OF ERROR LOGS, AUDIT LOGS AND QUALITY CONTROL (QC) FILES FROM THE TIME OF THE EVENT. NO ERRORS OCCURRED OR ENTRIES WERE LOGGED AT THE TIME OF THE EVENT AND QC RECOVERED WITHIN ACCEPTABLE RANGES. THE PATIENT'S CBC WAS RUN AND RESULTS REPORTED BEFORE THE TECHNOLOGIST DISCOVERED A CLOT IN ANOTHER TUBE DRAWN FROM THE SAME PATIENT.

    Description of Event or Problem · 1

    A TECHNOLOGIST REPORTED THAT AN ERRONEOUS LOW PLATELET RESULT WAS REPORTED. THE COMPLETE BLOOD COUNT (CBC) WAS RUN AND RESULTS REPORTED BEFORE A LABORATORY TECHNOLOGIST DISCOVERED A CLOT IN ANOTHER TUBE DRAWN FROM THE SAME PATIENT. THE PATIENT WAS REDRAWN. A NORMAL PLATELET COUNT WAS OBTAINED ON THE SECOND SAMPLE DRAWN. THE PATIENT RECEIVED ONE UNIT OF PLATELETS BASED ON THE ERRONEOUS PLATELET COUNT REPORTED ON THE FIRST SAMPLE. NO FURTHER HARM TO THE PATIENT WAS REPORTED. A SERVICE ENGINEER WAS DISPATCHED TO EVALUATE THE ANALYZER. HE RAN CALIBRATION MATERIAL WITH ALL VALUES RECOVERING WITHIN ASSAY RANGE, PATIENT SAMPLES WITH NO ISSUES FOUND COMPARED WITH OTHER INSTRUMENTS IN THE LINE. THE RBC/HGB CHAMBER FILLS AND DRAINS APPROPRIATELY. NO EVIDENCE OF LEAKING WAS FOUND. INSTRUMENT PRECISION CHECK MET SPECIFICATIONS. NO ANALYZER MALFUNCTION WAS IDENTIFIED. ALL LEVELS OF QC WERE RUN WITH RESULTS WITHIN ASSAY AND LABORATORY SPECIFIED RANGES. INSTRUMENT TESTED OPERATIONAL. INSIGHT PEER GROUP QUALITY CONTROL (QC) REPORTS WERE REVIEWED FOR LOT 6011 IN USE AT THE TIME OF THE EVENT ON FOR ALL ANALYZERS; NO PERFORMANCE ISSUES WERE OBSERVED. A FIRST TIME LOW PLATELET RESULT WAS NOT VERIFIED BY THE OPERATOR PRIOR TO REPORTING RESULTS. THE REPORTER STATED THAT THE PLATELET TRANSFUSION WAS GIVEN AS PART OF THE HEAD INJURY MEDICAL PROTOCOL HOWEVER, THE EXACT PROTOCOL IN USE BY THIS FACILITY IS UNKNOWN. USER ERROR CAUSED THIS PATIENT TO RECEIVE A TRANSFUSION OF PLATELETS, WITH THE POTENTIAL RISK OF INFECTION, EXPOSURE TO BLOOD BORNE PATHOGENS AND TRANSFUSION REACTION.

    Description of Event or Problem · 1

    THIS IS A FOLLOW-UP REPORT TO 1000515253-2016-00010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198331 SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other