BEUDAMED
    FDA Adverse Event Other Summary report: N

    SYSMEX XN-10

    MDR report key: 3978801 · Received July 1, 2014

    Report

    Report Number
    3009711478-2014-00017
    Event Type
    Other
    Date Received
    July 1, 2014
    Report Date
    June 3, 2014
    Manufacturer
    SYSMEX CORP.
    Product Code
    GKZ
    PMA / PMN Number
    K112605
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE XN-2000 INSTRUCTIONS FOR USE (IFU) STATES IN A DEDICATED WAGON (CABINET) THE REAGENT FOR THE ANALYZER IS STORED IN A N AREA BELOW. IT STATES TO OPEN AND CLOSE THE REAGENT STORAGE AREA BELOW. IT STATES TO OPEN AND CLOSE THE REAGENT STORAGE AREA USING HANDLE ON THE DEDICATED WAGON SLOWLY, AS THE DEDICATED WAGON IS CARRYING REAGENT THAT IS VERY HEAVY. AFTER CHANGING REAGENT CLOSE THE REAGENT STORAGE CABINET SLOWLY WITH CARE. IN THIS EVENT THE OPERATOR LEFT THE REAGENT ON THE FLOOR WITH THE CABINET DOOR OPEN. GOOD LABORATORY PRACTICES WOULD INDICATE USING SAFETY MEASURES RECOMMENDED BY THE OCCUPATIONAL SAFETY AND HEALTH (OSHA) TO KEEP WORKING AND WALKING AREAS FREE OF OBSTRUCTION TO PREVENT ACCIDENTAL USER INJURY. THE EMPLOYER IS RESPONSIBLE FOR ASSESSING RISK AND PROVIDING ADEQUATE TRAINING AND ENGINEERING CONTROLS FOR ALL REAGENTS AND OTHER MATERIALS USED IN A LABORATORY. A LABORATORY ASSOCIATE CONFIRMED THE OPERATOR WAS SENT TO THE EMERGENCY ROOM FROM TREATMENT IMMEDIATELY AFTER THE INCIDENT. THE OPERATOR RECEIVED STITCHES WHICH WERE REMOVED RECENTLY AND IS HEALING. THIS INCIDENT WILL BE REPORTED AS THE OPERATOR'S INJURY REQUIRED STITCHES TO CLOSE THE WOUND AND STOP BLEEDING.

    Description of Event or Problem · 1

    THE USER AN XN-2000 CONFIGURATION (S/N (B)(4) CONSISTING OF AN XN-10 AUTOMATED HEMATOLOGY ANALYZER (S/N (B)(4) ) TOGETHER WITH AN RU-20 REAGENT MANAGEMENT SYSTEM (S/N (B)(4) ) CONTACTED THE SYSMEX TECHNICAL ASSISTANCE CENTER (TAC) ON (B)(6) 2014 REGARDING A USER SAFETY ISSUE. THE OPERATOR SWITCHED FROM USING CELLPACK DST A CONCENTRATED REAGENT THAT IS RECONSTITUTED BY THE RU-20 AND SEATED INSIDE OF THE CONVEYER, TO NON-CONCENTRATE, CELLPACK DCL TO BYPASS THE RU-20. THE RU-20 IS AN ACCESSORY TO THE XN-2000 SYSTEM. THE USER STATED THE WAY THE TUBING WAS RUN IT REQUIRED THE BOX OF REGENT TO SIT ON THE FLOOR OUTSIDE OF THE CABINET. WHETHER THE TUBING LENGTH OR LOCATION OF TH EXN-10 TO WHICH IT WAS ATTACHED REQUIRED THE REAGENT BOX TO BE OUTSIDE OF THE CABINET IS UNKNOWN, BUT THE CABINET DOOR REMAINED OPEN. AN OPERATOR ON THE NIGHT SHIFT CUT HIS LEG ON THE OPEN CABINET DOOR REQUIRING STITCHES. THE USER REPORTED THE INCIDENT AND RECEIVED MEDICAL ATTENTION IN THE EMERGENCY ROOM. THE DAT THE INCIDENT OCCURRED IN UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385124 SYSMEX XN-10 AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORP. XN-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other