BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA 500

    MDR report key: 5001150 · Received August 13, 2015

    Report

    Report Number
    1226181-2015-00459
    Event Type
    Malfunction
    Date Received
    August 13, 2015
    Date of Event
    July 10, 2015
    Report Date
    July 16, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). THE CUSTOMER REPLACED STANDARD FLUIDS, PERFORMED ADVANCE CLEAN AND REPLACED SENSORS. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CHECKED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) CONNECTIONS, RAN DIAGNOSTICS, LEAK TESTING, DRAIN TESTING, AND CHECK 1 TESTING, ALL OF WHICH PASSED. THE CSE RAN A DILUENT CHECK AND QUALITY CONTROLS, AND BOTH RESULTED AS EXPECTED. THE CAUSE OF THE DISCORDANT NA, K AND CL RESULTS WAS RELATED TO ISSUES WITH THE IMT AND WAS RESOLVED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE DISCORDANT NA RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM FOR BEING ELEVATED. IT IS UNKNOWN IF DISCORDANT K AND CL RESULTS WERE REPORTED. THE SAMPLES WERE REPEATED ON AN ALTERNATE DIMENSION VISTA INSTRUMENT, RESULTING AS EXPECTED. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534819 DIMENSION VISTA 500 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1