BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XN-10

    MDR report key: 17577727 · Received August 18, 2023

    Report

    Report Number
    1000515253-2023-00005
    Event Type
    Injury
    Date Received
    August 18, 2023
    Date of Event
    June 28, 2023
    Report Date
    August 18, 2023
    Manufacturer
    SYSMEX CORPORATION, I SQUARE
    Product Code
    GKZ
    UDI-DI
    04987562424214
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE XN SERIES (XN-3000/XN-3100) INSTRUCTIONS FOR USE (IFU) PROVIDE THE FOLLOWING INTENDED USE STATEMENT: "THE XN SERIES MODULES (XN-10, XN-20) ARE QUANTITATIVE MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZERS INTENDED FOR IN VITRO DIAGNOSTIC USE IN SCREENING PATIENT POPULATIONS FOUND IN CLINICAL LABORATORIES. THE XN SERIES MODULES CLASSIFY AND ENUMERATE THE FOLLOWING PARAMETERS IN WHOLE BLOOD: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, PLT (PLT-I, PLT-F), NEUT%/#, LYMPH%/#, MONO%/#, EO%/#, BASO%/#, IG%/#, RDW-CV, RDW-SD, MPV, NRBC%/#, RET%/#, IPF, IRF, RET-HE AND HAS A BODY FLUID MODE FOR BODY FLUIDS." THE CUSTOMER, A USER OF A SYSMEX XN-3100 AUTOMATED HEMATOLOGY SYSTEM, CONSISTING OF TWO XN-10 AUTOMATED HEMATOLOGY ANALYZERS, CONTACTED THE TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2023, TO REPORT XN-10, SERIAL NUMBER (SN) (B)(6), HAD GENERATED X-BARM ERRORS FOR HGB, MEAN CORPUSCULAR HEMOGLOBIN (MCH) AND MEAN CORPUSCULAR HEMOGLOBIN CONCENTRATION (MCHC) PARAMETERS. PER CHAPTER 8 OF THE IFU, THE X-BARM QUALITY CONTROL (QC) PROGRAM CALCULATES A WEIGHTED AVERAGE OF BATCHES OF NORMAL PATIENT SAMPLES AND PLOTS THE RESULTING VALUE AS CONTROL DATA. REVIEW OF ERROR LOG FOR XN-10, SN (B)(6), DOCUMENTS THE X-BARM CONTROL ERRORS AT 10:02, 11:56, AND 13:32 ON (B)(6) 2023. THESE ERRORS ARE GENERATED WHEN AN ABNORMALITY IS DETECTED IN THE QUALITY CONTROL DATA. PER CHAPTER 14 IN THE IFU, THE OPERATOR IS INSTRUCTED TO CHECK THE PARAMETER(S) THAT EXCEEDED THE QC LIMITS, AND THEN CLICK [ACCEPT]. THE USER ACKNOWLEDGED THE X-BARM CONTROL ERRORS. A SERVICE ENGINEER (SE) WAS DISPATCHED TO INSPECT THE ANALYZER. THE SE PERFORMED ROUTINE SERVICE AND ANALYSIS OF COMMERCIAL QC PRODUCT RECOVERED IN RANGE. NO FURTHER REPORTS OF X-BARM CONTROL ERRORS FOR THE HGB, MCH AND MCHC PARAMETERS WERE GENERATED. THE CUSTOMER RE-ANALYZED SAMPLES PROCESSED ON XN-10, SN (B)(6), AND IDENTIFIED 85 SAMPLES WHICH REQUIRED CORRECTED REPORTS. ON JULY 19, 2023, THE CUSTOMER NOTIFIED SYSMEX OF UNNECESSARY TREATMENT, TRANSFUSION OF ONE PACK OF RED BLOOD CELLS, FOR ONE PATIENT BASED ON ERRONEOUSLY LOW HGB RESULTS GENERATED FROM THE ANALYSIS OF SAMPLE ID (SID) (B)(6). THE SUSPECT ANALYSES FOR SAMPLE ID (SID) (B)(6) WERE JUDGED "POSITIVE" WITH INTERPRETIVE PROGRAM (IP) MESSAGES ALERTING THE OPERATOR TO POSSIBLE SAMPLE ABNORMALITY. PER CHAPTER 11 IN THE IFU, RESULTS WITHOUT AN ERROR MESSAGE ARE CATEGORIZED AS "POSITIVE" OR "NEGATIVE" BASED UPON PRESET CRITERIA, SOME OF WHICH ARE LABORATORY-DEFINED. THE SYSTEM BASES JUDGMENTS ON COMPREHENSIVE SURVEYS OF NUMERICAL DATA, PARTICLE-SIZE DISTRIBUTIONS, AND SCATTERGRAMS. FLAGS AND MESSAGES, COMMUNICATED THROUGH IP MESSAGES, INDICATE THE ANALYZER'S FINDINGS, AND NOTIFY THE OPERATOR OF POSSIBLE SAMPLE SPECIFIC ABNORMALITIES. FURTHER VERIFICATION OF ACCURATE RESULTS IS RECOMMENDED PRIOR TO REPORTING TO THE CLINICIAN. THE SUSPECT ANALYSES FOR SID (B)(6) GENERATED ERROR/RULE COMMENTS ALERTING THE OPERATOR TO VERIFY RESULTS PRIOR TO REPORTING. PER CHAPTER 10 IN THE IFU, ERROR/RULE COMMENTS INDICATE THE ANALYSIS RESULTS NEED TO BE REVIEWED AND REANALYZED. THE INVESTIGATION DETERMINED AN ANALYZER MALFUNCTION OF UNKNOWN ORIGIN CAUSED THIS EVENT, WHICH WAS RESOLVED WITH ROUTINE SERVICING ACTIVITIES BY THE SE. THE ANALYZER ALERTED THE OPERATOR TO ABNORMALITIES BY FLAGGING SUSPECT RESULTS AND GENERATING X-BARM CONTROL ERRORS.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED ONE PATIENT RECEIVED AN UNNECESSARY RED BLOOD CELL TRANSFUSION BASED ON AN ERRONEOUS LOW HEMOGLOBIN (HGB) RESULT GENERATED BY THE ANALYZER. NO NEGATIVE PATIENT IMPACT FROM THE TRANSFUSION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2339729 SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION, I SQUARE XN-10 04987562424214

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Other