BEUDAMED
    FDA Adverse Event Death Summary report: N

    XE-5000

    MDR report key: 6197456 · Received December 21, 2016

    Report

    Report Number
    1000515253-2016-00031
    Event Type
    Death
    Date Received
    December 21, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 21, 2016
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K071967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER IS ULTIMATELY RESPONSIBLE FOR USING SYSMEX INSTRUMENTATION ACCORDING TO DIRECTIONS. THE USER IS ALSO RESPONSIBLE FOR ACCURATE IDENTIFICATION OF PATIENT SAMPLES PRIOR TO ANALYSIS AND REPORTING. NO EVALUATION REQUIRED.

    Additional Manufacturer Narrative · 1

    THE FACILITY WAS UNWILLING TO PROVIDE ANY ADDITIONAL INFORMATION REGARDING PATIENT'S CONDITION, DIAGNOSIS, TREATMENT AND DETAILS OF EXPIRATION. THE CAUSE OF DEATH WAS NOT PROVIDED. THE XE-5000 ANALYZER HAS A DELTA CHECK PROGRAM THAT DETECTS THE DISPARITY IN THE WBC, HGB, MCV, AND PLT RESULTS, BUT THE USER DID NOT CONFIRM WHETHER DELTA CHECKS OR THE INSTRUMENT WERE USED AT THE TIME OF ANALYSIS. THE SAMPLE FOR PATIENT 1 WAS ANALYZED IN MANUAL MODE WITH BARCODE SCANNER. HGB OF 6.3 G/DL WAS GENERATED AND HELD IN THE LIS. THIS RESULT WAS NOT REPORTED TO THE CLINICIAN. PATIENT 1 SAMPLE ID DISPLAYED ATTRIBUTE "B", MEANING THE ID WAS SCANNED IN WITH A BAR CODE ID READER. THE OPERATOR MUST AT A MINIMUM, PRESS "ENTER" TO CONFIRM THE DISPLAYED SAMPLE ID (REGARDLESS OF HOW IT IS ENTERED), THEN ASPIRATE THE SAMPLE. THE OPERATOR FAILED TO ENTER AN ID NUMBER EITHER BY BARCODE OR MANUALLY FOR PATIENT 2, SO THE SAMPLE ID ASSIGNMENT WAS LEFT TO THE ANALYZER TO "AUTO-INCREMENT" TO ASSIGN A UNIQUE SAMPLE ID. THE ANALYZER PERFORMED ACCORDING TO SPECIFICATION. PATIENT 2 SAMPLE WAS SUBSEQUENTLY RUN IN MANUAL MODE. THE SAMPLE ID DISPLAYED THE ATTRIBUTE "A", MEANING ID AUTO-INCREMENT; HOWEVER, THE ANALYZER CANNOT INCREMENT TO ASSIGN A UNIQUE SAMPLE ID BECAUSE OF THE ALPHA CHARACTER AT THE END OF THE SAMPLE NUMBER. ONLY NUMERICAL DIGITS CAN BE INCREMENTED. THE SAMPLE ID FROM PATIENT 1 REMAINED DISPLAYED ON THE MANUAL SAMPLE ENTRY SCREEN. THE OPERATOR PRESSED "ENTER", AND ANALYZED SAMPLE 2. THE HGB=15.1 G/DL WAS GENERATED, AND THIS RESULT WAS INCORRECTLY REPORTED TO THE CLINICIAN. ACCORDING TO CORE LABORATORY MANAGER, BOTH SETS OF RESULTS WITH THE SAME SAMPLE ID WERE HELD IN THE LIS. THE OPERATOR IS RESPONSIBLE FOR SELECTING ONE SET OF RESULTS FOR RELEASE TO THE HOSPITAL INFORMATION SYSTEM (HIS). THE OPERATOR INVOLVED COULD NOT RECALL REVIEWING THE RESULTS OR MAKING A SELECTION PRIOR TO REPORTING. THE LABORATORY MANAGER ACKNOWLEDGED THE VARIANCE BETWEEN THE TWO SETS OF RESULTS, SHOULD HAVE CAUSED THE OPERATOR TO CONDUCT FURTHER INVESTIGATION PRIOR TO SELECTING AND RELEASING A RESULT. THE STEPS FOR MANUAL ANALYSIS PER THE XE-5000 INSTRUCTIONS FOR USE - CHAPTER 6 ARE SUMMARIZED BELOW. THE INSTRUMENT MUST BE IN READY STATUS. THE READY LED SHOULD BE LIT. PRESS THE MANUAL KEY ON THE MAIN UNIT PANEL KEYPAD. THE SAMPLE NO. SETTING SCREEN WILL APPEAR ON THE LCD. USING THE NUMERIC KEYS, INPUT THE SAMPLE ID NUMBER, OR SCAN THE BARCODE USING A HANDHELD BARCODE SCANNER (OPTION). THE ID NUMBER IS DISPLAYED. IF THE ANALYSIS MODE IS NOT SET FOR MANUAL MODE ASPIRATION, SET IT TO "MANUAL" MODE. SET THE TEST PANEL TO RUN (CBC, CBC+DIFF) ETC. SET THE "SAMPLE", TYPE TO NORMAL (WHOLE BLOOD), BODY FLUID OR HPC (HUMAN PROGENITOR CELLS). AFTER ALL THE SETTINGS ARE SELECTED, PRESS THE ENTER KEY TO CONFIRM. ASPIRATE THE SAMPLE.

    Description of Event or Problem · 1

    PATIENT 1 (SID (B)(6)) WAS ANALYZED ON (B)(6) 2016 IN THE MANUAL MODE AND A LOW HGB OF 6.3 G/DL WAS GENERATED. SUBSEQUENTLY, PATIENT 2 (SID (B)(6)) WAS ANALYZED IN THE MANUAL MODE AND GENERATED A NORMAL HGB OF 15.1 G/DL. REVIEW OF THE ANALYZER'S SAMPLE LIST REVEALED THAT AFTER PATIENT 1 WAS ANALYZED, THE OPERATOR FAILED TO ENTER THE SAMPLE ID OF PATIENT 2. WHEN RUNNING IN MANUAL MODE, THE USER MUST SCAN OR MANUALLY ENTER THE SAMPLE ID TO PROPERLY IDENTIFY A SAMPLE. SINCE THIS WAS NOT PERFORMED, PATIENT 1 SAMPLE ID REMAINED IN THE SAMPLE ID FIELD, AND RESULTS FROM PATIENT 2 WERE ATTACHED TO PATIENT 1 AND RELEASED TO THE CLINICIAN INCORRECTLY. TWELVE HOURS LATER, PATIENT 1 WAS RE-DRAWN AND ANALYZED AS SID (B)(6). A HGB OF 4.6 G/DL WAS GENERATED AND REPORTED TO THE CLINICIAN. THIS EVENT IS BEING REPORTED TO THE FDA DUE TO REPORT OF PATIENT DEATH. OPERATOR REPORTED THAT PATIENT HAD MANY MEDICAL CONDITIONS. PATIENT CONDITION, DIAGNOSIS AND TREATMENTS DURING THE TIMES OF ANALYSIS AND DETAILS OF EVENTS LEADING TO PATIENT EXPIRATION WERE NOT PROVIDED. IT IS UNKNOWN IF PATIENT DEATH WAS ASSOCIATED WITH TREATMENT OR LACK OF TREATMENT BASED ON THE INCORRECT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844688 XE-5000 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-5000

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Death