BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 120 WITH AUTOSAMPLER

    MDR report key: 4076030 · Received September 9, 2014

    Report

    Report Number
    2432235-2014-00506
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 14, 2014
    Report Date
    August 15, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    GKZ
    PMA / PMN Number
    K971998
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS HEALTHCARE DIAGNOSTICS INC. FILED THE INITIAL MDR (2432235-2014-00506) ON SEPTEMBER 9, 2014. ON 9/25/2014: ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS INC. HAS INVESTIGATED THE ISSUE AND HAS DETERMINED THAT THE CAUSE OF THE EVENT IS USER ERROR. THE CUSTOMER RELEASED RESULTS PRODUCED BY THE ADVIA 120 WITH AUTOSAMPLER DESPITE QUALITY CONTROL BEING OUT OF SPECIFICATION. NO ADDITIONAL PATIENT RESULTS CAN BE OBTAINED AS THE SOFTWARE WAS RELOADED ON THE ADVIA 120 WITH AUTOSAMPLER AND THE PATIENT DATA IS NO LONGER AVAILABLE. THE CUSTOMER HAS CONFIRMED THAT NO PHYSICIANS HAVE QUESTIONED THE RESULTS FOR THE PATIENT SAMPLES THAT WERE RUN WHEN THE CONTROLS WERE NOT IN RANGE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) TECHNICAL APPLICATIONS SPECIALIST (TAS) WAS DISPATCHED TO THE CUSTOMER SITE, AS A FOLLOW UP TO THE SOFTWARE INSTALLATION VISIT. THE TAS DISCOVERED THAT THE ADVIA 120 WITH AUTOSAMPLER WAS RUNNING WITH DEFAULT CALIBRATION FACTORS AND GAINS. THE CUSTOMER NEVER INVESTIGATED WHY THE QUALITY CONTROL MATERIAL FAILED SPECIFICATIONS NOR CALLED SIEMENS REGARDING THE ISSUE. THE TAS RESTORED THE SYSTEM WITH THE PRE-SOFTWARE INSTALL CALIBRATION FACTORS AND GAINS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. CLINICAL SERVICE ENGINEER (CSE) RE-INSTALLED SOFTWARE ON AN ADVIA 120 WITH AUTOSAMPLER SYSTEM. THE CUSTOMER RAN QUALITY CONTROL MATERIAL AND ABOUT 100 PATIENT SAMPLES WITH THE DEFAULT CALIBRATION FACTORS AND GAINS SET ON THE ADVIA 120 WITH AUTOSAMPLER SYSTEM, INSTEAD OF THE PRE-SOFTWARE INSTALLATION CALIBRATION FACTORS AND GAINS. QUALITY CONTROL MATERIAL FAILED SPECIFICATIONS AND PATIENT RESULTS WERE RELEASED TO PHYSICIANS, WHO HAVE NOT QUESTIONED THE RESULTS. IT IS UNKNOWN IF THE CUSTOMER REPEATED ALL OF THE PATIENT SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO RELEASING THE PATIENT SAMPLES DESPITE QUALITY CONTROL MATERIAL FAILING SPECIFICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552624 ADVIA 120 WITH AUTOSAMPLER ADVIA 120 WITH AUTOSAMPLER GKZ SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 120 WITH AUTOSAMPLER

    Patients

    Seq Age Sex Outcome Treatment
    1