BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSMEX XN-10

    MDR report key: 10445936 · Received August 24, 2020

    Report

    Report Number
    1000515253-2020-00024
    Event Type
    Injury
    Date Received
    August 24, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 24, 2020
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE XN-9000 INSTRUCTIONS FOR USE (IFU), CHAPTER 11 - CHECKING DETAILED ANALYSIS INFORMATION (DATA BROWSER), SECTION 11.5 - INTERPRETIVE PROGRAM (IP) MESSAGES, DETAILS THE METHOD IN WHICH THE ANALYZER CONVEYS ITS FINDINGS. 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 OF POSSIBLE SAMPLE SPECIFIC ABNORMALITIES. ANY FLAG NOT GENERATED INDICATES THE CRITERIA DEFINED WERE NOT MET. REVIEW OF SAMPLE DATA DEMONSTRATES THAT THE SETTING FOR IP MESSAGE "ANEMIA" WAS NOT SET TO THE DEFAULT SETTING OF HEMOGLOBIN (HGB) < 10 G/DL. THE ANALYSES OF SAMPLES (B)(6) WOULD HAVE BEEN JUDGED "POSITIVE" DUE TO HGB RESULTS OF < 10 G/DL, HAD THE DEFAULT SETTING BEEN APPLIED. NO ANALYZER DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR AN UNRELATED PROCEDURE. A BLADDER BIOPSY WAS PERFORMED YIELDING INCONCLUSIVE RESULTS, PROMPTING REFERRAL OF THE SAMPLE TO A REFERENCE LABORATORY FOR EVALUATION. BLOOD SAMPLE ANALYSES FOR COMPLETE BLOOD COUNT (CBC) AND CBC WITH DIFFERENTIAL (DIFF) PERFORMED OVER THE COURSE OF THE HOSPITAL STAY WERE JUDGED "NEGATIVE". A CBC WITH DIFF ANALYSIS COLLECTED ON THE DAY OF DISCHARGE WAS JUDGED "POSITIVE", PROMPTING A SMEAR REVIEW AND DISCOVERY OF BLAST CELLS (BLAST). A SUBSEQUENT REVIEW OF SMEARS FROM PRIOR SAMPLES ALSO YIELDED BLASTS. THE PATIENT HAD BEEN DISCHARGED BEFORE THE DISCOVERY OF BLASTS. THE PATIENT WAS READMITTED AND A BONE MARROW BIOPSY WAS PERFORMED. THE PATIENT DIAGNOSIS OF ACUTE (NON-PROMYELOCYTIC) MYELOID LEUKEMIA WAS DELAYED BY 9 DAYS. NO HARM TO THE PATIENT WAS REPORTED DUE TO THE DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    905603 SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization