BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XT-2000I

    MDR report key: 10289869 · Received July 17, 2020

    Report

    Report Number
    1000515253-2020-00020
    Event Type
    Injury
    Date Received
    July 17, 2020
    Date of Event
    July 7, 2020
    Report Date
    July 21, 2020
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K021241
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    "RELEVANT TESTS/LABORATORY DATA, INCLUDING DATES", THE COLUMN HEADER "XN SN#" WAS CORRECTED TO REFLECT "XT SN#".

    Additional Manufacturer Narrative · 1

    A SYSMEX SERVICE ENGINEER (SE) WAS DISPATCHED TO EVALUATE THE ANALYZER. THE SE REPLACED VALVE UNIT NO.165 TO RESOLVE THE ISSUE. PART REPLACEMENT WAS PART OF ROUTINE SERVICING DUE TO THE EXTENDED AGE AND USE OF THE ANALYZER. NO SYSTEMIC DEFICIENCY WAS IDENTIFIED. THE SYSMEX XT-2000I INSTRUCTION FOR USE (IFU), CHAPTER 16 - APPENDIX, SECTION 16.1 - IP MESSAGE, DETAILS THE METHOD IN WHICH THE ANALYZER CONVEYS ITS FINDINGS. "THE IPU DISPLAYS AND PRINTS HEMATOLOGY INFORMATION IN A FORMAT DESIGNED TO AID IN THE SEPARATION OF POSITIVE AND NEGATIVE DATA RESULTS. ALL ANALYZED SAMPLES WITHOUT ANALYSIS ERRORS CAN BE SEPARATED INTO A POSITIVE OR NEGATIVE CATEGORY ACCORDING TO PRESET CRITERIA. THE SYSTEM BASES ITS JUDGMENTS ON COMPREHENSIVE SURVEYS OF NUMERICAL DATA, PARTICLE SIZE DISTRIBUTIONS, SCATTERGRAMS, AND PROVIDES EASY-TO-UNDERSTAND FLAGS/MESSAGES INDICATING THE INSTRUMENT'S FINDINGS. THESE FLAGS/MESSAGES ARE REFERRED TO AS "IP (INTERPRETIVE PROGRAM) MESSAGES". THE TWO INITIAL ANALYSES WERE JUDGED "NEGATIVE". ANY FLAG NOT GENERATED INDICATES THE CRITERIA DEFINED WERE NOT MET. THE USER-DEFINED SETTING FOR "ANEMIA" AND "HYPOCHROMIA" WERE NOT PROVIDED. CHAPTER 16 - APPENDIX, SECTION 16.1 - IP MESSAGE, DISCUSSES THE DEFAULT SETTING FOR ANEMIA, WHICH IS HGB <10.0 G/DL AND HYPOCHROMIA WHICH IS MCHC <29.0 G/DL. HAD THE USER SET THE ANEMIA AND HYPOCHROMIA FLAGS TO THE DEFAULT SETTING, THE ANALYZER WOULD HAVE ALERTED THE OPERATOR WITH A POSITIVE JUDGEMENT. THE SECOND ANALYSIS GENERATED AN ACTION MESSAGE: "DELTA CHECK FAILURE. CHECK SAMPLE". THE PURPOSE OF A DELTA CHECK FAILURE IS TO ALERT THE USER OF A SIGNIFICANT DIFFERENCE BETWEEN A PATIENT'S CURRENT RESULT AND A PREVIOUS RESULT. GOOD LABORATORY PRACTICE REQUIRES THAT A SYSTEM BE IN PLACE FOR CONFIRMING AND REPORTING CRITICAL VALUES AND/OR SIGNIFICANT CHANGES IN THE PATIENT TEST RESULTS (DELTA CHECKS, PREVIOUS RESULT REVIEWS, VERIFICATION BY ANOTHER METHOD, PERIPHERAL SMEAR EXAMINATION, ETC.). THE TWO INITIAL ANALYSES GENERATED HCT RESULTS THAT WERE INCONSISTENT WITH THE HGB RESULTS AND MCH AND MCHC RESULTS WERE ABNORMALLY LOW, FURTHER INDICATING POSSIBLE SAMPLE ABNORMALITY. ABNORMAL INDICES AND THE USUAL RELATIONSHIP BETWEEN HGB/HCT (MCHC) MAY REFLECT A SPECIMEN ISSUE OR IMPROPER FUNCTIONING IN AUTOMATED HEMATOLOGY ANALYZERS. THE USER WAS ALERTED OF POSSIBLE SAMPLE RESULT ABNORMALITY BY THE GENERATION OF AN ACTION MESSAGE AND INCONSISTENT ANALYSIS RESULTS. THE USER FAILED TO RECOGNIZE THE SAMPLE RESULT ABNORMALITY AND DID NOT VERIFY ACCURATE RESULTS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    A USER IN (B)(6) REPORTED THE ANALYZER GENERATED ERRONEOUS LOW HEMOGLOBIN (HGB), MEAN CORPUSCULAR HEMOGLOBIN (MCH), AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) RESULTS. A RED BLOOD CELL (RBC) TRANSFUSION WAS ADMINISTERED TO ONE PATIENT BASED ON AN ERRONEOUS LOW HGB RESULT. NO SERIOUS HARM TO THE PATIENT FROM THE RBC TRANSFUSION WAS REPORTED. A CORRECTED REPORT WAS ISSUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752163 SYSMEX XT-2000I AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XT-2000I

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other