BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA WORKCELL

    MDR report key: 3955204 · Received July 24, 2014

    Report

    Report Number
    2432235-2014-00486
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K083339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE ADVIA WORKCELL. THE CSE CHECKED THE ALIGNMENTS AT THE GATES AND TRAYS AND SET THE GRIPPER ALIGNMENT. THE CAUSE OF THE DROPPED SAMPLE TUBE IS UNKNOWN. THIS DEVICE IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE ADVIA WORKCELL SAMPLE MANAGER ROBOT DROPPED A SAMPLE TUBE, CAUSING IT TO SPILL. THE LABORATORY DID NOT HAVE ADDITIONAL SAMPLE TUBES FROM THE PATIENT. THE SAMPLE HAD BEEN COLLECTED FROM A PEDIATRIC PATIENT AT A REMOTE SITE. THE CUSTOMER STATED THAT THE SITE WOULD NEED TO REDRAW THE PATIENT TO OBTAIN A NEW SAMPLE FOR TESTING. THE TEST ORDER FOR THE SAMPLE WAS A BASIC METABOLIC PANEL (BMP). IT IS UNKNOWN IF THE PATIENT WAS REDRAWN OR WHAT THE RESULTS WERE. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DROPPED SAMPLE TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434501 ADVIA WORKCELL LABORATORY AUTOMATION SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA WORKCELL

    Patients

    Seq Age Sex Outcome Treatment
    1