BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 1500

    MDR report key: 6872979 · Received September 18, 2017

    Report

    Report Number
    2517506-2017-00713
    Event Type
    Malfunction
    Date Received
    September 18, 2017
    Date of Event
    August 28, 2017
    Report Date
    September 18, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. (SIEMENS) CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO INSPECT THE SYSTEM. THE CSE CHECKED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) MODULE AND IMT PROBE, RAN PASSING CHECK 1 ON IMT PROBE, PERFORMED POWER FLUSH AND ROTARY VALVE LEAK TEST, REPLACED ROTARY VALVE, AUTO ALIGNED IMT MODULE AND PROBE, PERFORMED IMT PROBE SAMPLE PORT ALIGNMENT, REPEATED THE LEAK TEST AND CHECK 1 PASSED WITH NO ERRORS. A PERISTALTIC PUMP TUBE AND THE IMT MODULE WERE ALSO REPLACED. THE CAUSE OF THE DISCORDANT FALSELY HIGH SODIUM AND POTASSIUM RESULTS ARE UNKNOWN. THE ANALYZER IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER ACTION REQUIRED.

    Description of Event or Problem · 1

    A GROUP OF FIVE PATIENT SAMPLES GAVE DISCORDANT FALSELY HIGH TEST RESULTS FOR SODIUM OR POTASSIUM ON A DIMENSION VISTA 1500 SYSTEM. THE RESULTS WERE REPORTED TO THE PHYSICIAN(S) WHO QUESTIONED THE RESULTS. THE SAME PATIENT SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA 1500 SYSTEM AND CORRECTED REPORTS WERE ISSUED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT FALSELY HIGH SODIUM OR POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    653740 DIMENSION VISTA 1500 DIMENSION VISTA 1500 JJE SIEMENS HEALTHCARE DIAGNOSTICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1