BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSEMX XE-2100 ANALYZER

    MDR report key: 2944971 · Received February 1, 2013

    Report

    Report Number
    1422681-2013-00002
    Event Type
    Injury
    Date Received
    February 1, 2013
    Report Date
    January 4, 2013
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPU AT THE CUSTOMER SITE WAS NOT CONNECTED TO THE (B)(4) SNCS REMOTE MONITORING SOFTWARE WITH THE FLASH DRIVE THAT BACKS UP THE ANALYZER SETTINGS DAILY, INCLUDING THE FORMAT FILE. WHEN THE IPU WAS REPLACED, THE SETTINGS WERE NOT PRESENT ON A FLASH DRIVE TO REINSTALL. THE FSR WAS ABLE TO REINSTALL THE CALIBRATION FILES, BUT THE SETTING IN THE IPU WERE THE STANDARD FORMAT B. PROCEDURES DIRECT THE FSR TO VERIFY THE FORMAT SETTING, BUT THE MISMATCH OF THE STANDARD FORMAT FILE WITH THE LIS WAS NOT DETECTED. CAPA (B)(4) WAS OPENED TO DOCUMENT INVESTIGATION ACTIONS TAKEN TO PREVENT RECURRENCE. INSTALLATION OF SNCS AGENT 2.4.4 WITH FLASH DRIVE (TECHNICAL SERVICE BULLETIN 12-013R) RELEASED 01/17/2013 IS ON-GOING, AND WILL PROVIDE BACK-UP OF SETTING FOR REINSTALLATION IF AN IPU IS REPLACED. SERVICE PROCEDURES WILL BE REVIEWED AND REVISED AS NEEDED TO ASSURE INSTALLATION AND TESTING OF CORRECT DATA OUTPUT FORMAT (A OR B).

    Description of Event or Problem · 1

    THE USER OF AN XE-2100 AUTOMATED HEMATOLOGY ANALYZER (SERIAL #(B)(4)) REPORTED TO SYSMEX THAT THE NUCLEATED RED BLOOD CELL (NRBC) PERCENT (PER 100 WBC) FROM THE INSTITUTION'S CANCER CENTER WAS CROSSING INTO THE LABORATORY INFORMATION SYSTEM (LIS) WITH A VALUE THAT WAS INCORRECT BY ONE DECIMAL PLACE. FOR EXAMPLE, IF THE SYSMEX ANALYZER PRINTOUT READ 7.40 PER 100 WBC, THE RESULT CROSSED INTO THE CERNER LIS AS 0.74 PER 100 WBC. THE USER DISCOVERED THE INCORRECT NRBC RESULTS IN THE LIS ON 01/04/2013, AND DETERMINED THAT THE INACCURATE REPORTS BEGAN ON OR AROUND (B)(6) 2012, WHEN THE XE INFORMATION PROCESSING UNIT (IPU) WAS REPLACED BY THE FIELD SERVICE REP (FSR). THE IPU CONTAINED THE STANDARD DATA OUTPUT FORMAT B THAT EXPRESSES NRBC WITH 5 DIGITS, BUT THE CUSTOMER'S LIS REQUIRED FORMAT A THAT REPORTS NRBC WITH 4 DIGITS, CAUSING THE INCORRECT NRBC RESULTS IN THE LIS. THE LAB'S PATHOLOGIST REVIEWED THE RESULTS ON 4884 PTS WITH RESULTS REPORTED TO THE LIS, SOME OF WHICH CONTAIN INCORRECT NRBC. CORRECTED REPORTS WERE ISSUED FOR 20 PTS. PHYSICIANS WERE CONTACTED FOR EACH PT AFFECTED BY (B)(4) 2013. NO IMPACT TO PT MANAGEMENT BASED ON THE PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45172 SYSEMX XE-2100 ANALYZER AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-2100

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK