BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 7165714 · Received January 4, 2018

    Report

    Report Number
    2517506-2018-00001
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 13, 2017
    Report Date
    February 22, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    UDI-DI
    00630414949581
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE INITIAL MDR 2517506-2018-00001 WAS FILED ON 04-JAN-2018. ADDITIONAL INFORMATION (31-JAN-2018): A SIEMENS HEADQUARTERS SUPPORT CENTER SPECIALIST REVIEWED THE INSTRUMENT DATA, WHICH WAS INDICATIVE OF FLUID FLOW PROBLEM OR AN OBSTRUCTION IN THE INTEGRATED MULTI-SENSOR TECHNOLOGY SYSTEM CAUSING IMPRECISE MEASUREMENTS. THE SIEMENS CUSTOMER SERVICE ENGINEER'S OBSERVATIONS AND RESOLUTION INDICATES THAT THERE WAS A MAINTENANCE NEED AT THE TIME OF THE EVENT OCCURRENCE. THE ISSUE WAS RESOLVED WITH A SERVICE VISIT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER. AFTER THE PATIENT SAMPLE WAS RUN, THE CUSTOMER RAN QUALITY CONTROLS, WHICH WERE OUT OF RANGE. THE CUSTOMER FOUND INTEGRATED MULTI-SENSOR TECHNOLOGY (IMT) PROBE PRESSURE TRANSDUCER CHARGE PROBE DILUENT FAILURE AND CHARGE PROBE IMT DILUENT EXCESSIVE NOISE ERRORS ON THE DAY DISCORDANT RESULT WAS OBTAINED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT, THE CSE FOUND THAT THE IMT DILUENT METERING SYRINGE WAS LEAKING AIR INTO THE SYSTEM. THE CSE REPLACED THE SYRINGE MOTOR, DILUENT VALVE, 3-WAY SOLENOID VALVE, AND POSITIVE DISPLACEMENT PUMP. THE CSE RAN PROBE TEST AND QUALITY CONTROLS WITHOUT ANY ISSUE. THE CSE ALSO RAN DILUENT CARRYOVER STUDY AND ELECTROLYTES PRECISION RUNS WITHOUT PROBLEM. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA RESULT ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN MANUFACTURING SPECIFICATIONS. NO FURTHER EVALUATION OF DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING LOWER AND MATCHING THE PATIENT'S HISTORY. THE CORRECTED RESULT FROM THE ALTERNATE DIMENSION VISTA INSTRUMENT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCE DUE TO THE DISCORDANT, FALSELY ELEVATED NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8873 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION VISTA 500 00630414949581

    Patients

    Seq Age Sex Outcome Treatment
    1