BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XE-2100DC

    MDR report key: 7003261 · Received November 6, 2017

    Report

    Report Number
    1000515253-2017-00038
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 11, 2017
    Report Date
    November 6, 2017
    Manufacturer
    SYSMEX CORPORATION
    Product Code
    GKZ
    PMA / PMN Number
    K051459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SYSMEX SERVICE ENGINEER (SE) CONFIRMED THE INVOLVED OBJECT THAT CAUSED THE INJURY HAD BEEN DISCARDED. THE SE COULD NOT CONFIRM THAT THE OBJECT, WHICH CAUSED THE INJURY, WAS FROM THE ASPIRATION NEEDLE OF THE ANALYZER. THE INFORMATION IS NO LONGER PRESENT ON THE ANALYZER TO INVESTIGATE THE ALLEGATION OF A MALFUNCTION THAT OCCURRED WHICH CAUSED THE BROKEN NEEDLE. THE SE REPORTED THAT THE ANALYZER WAS PERFORMING WITHIN SPECIFICATIONS. THIS EVENT WAS REPORTED BECAUSE THE OPERATOR RECEIVED ANTI-VIRAL MEDICATION TO GUARD AGAINST DEVELOPMENT OF BLOOD-BORNE DISEASE.

    Description of Event or Problem · 1

    THE LABORATORY SUPERVISOR STATED THAT THE OPERATOR REMOVED THE SAMPLE RACK AND TUBE. AT THAT TIME, HE FELT A PUNCTURE AND OBSERVED A METAL PIECE PROTRUDING FROM THE TOP OF THE SPECIMEN TUBE. THE LABORATORY SUPERVISOR STATED THAT THE METAL PIECE WAS FROM THE ASPIRATION NEEDLE FROM THE ANALYZER. THE INJURY WAS TO THE OPERATOR'S RIGHT INDEX FINGER. THE OPERATOR WASHED THE AFFECTED AREA AND WAS PRESCRIBED ANTI-VIRAL MEDICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782643 XE-2100DC AUTOMATED HEMATOLOGY ANALYZER GKZ SYSMEX CORPORATION XE-2100DC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other