BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2120 WITH DUAL ASPIRATE

    MDR report key: 2841899 · Received November 21, 2012

    Report

    Report Number
    2432235-2012-00404
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K102644
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS DETERMINED THAT THE FIELD SERVICE ENGINEER (FSE) HAD LEFT THE BOX IN AN OUT-OF-THE-WAY LOCATION. THE CAUSE OF THE EVENT WAS THE OPERATOR NOT WAITING FOR THE SIEMENS FSE TO DISPOSITION THE STATUS OF THE PARTS INSIDE THE BOX AND INSTEAD DECIDING TO MOVE THE BOX WITHOUT CONTACTING THE FSE.

    Description of Event or Problem · 1

    THE OPERATOR OF AN ADVIA 2120 WITH DUAL ASPIRATE TRIED TO LIFT A BOX WHICH CONTAINED A PART A SIEMENS FIELD SERVICE ENGINEER (FSE) HAD REPLACED DURING A RECENT VISIT. THE BOX FELL ON THE OPERATOR'S FOOT. THE OPERATOR VISITED THE EMERGENCY ROOM. AN X-RAY DID NOT SHOW ANY FRACTURES. HOWEVER, THE OPERATOR HAD SWOLLEN TOES. THE OPERATOR HAD TO KEEP HER FOOT IN A BOOT AND WAS OUT OF WORK FOR TWO WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 2120 WITH DUAL ASPIRATE HEMATOLOGY ANALYZER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2120 WITH DAA AUTOSAMPLER (INSTRUMENT ONLY)

    Patients

    Seq Age Sex Outcome Treatment
    1