BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3052051 · Received April 11, 2013

    Report

    Report Number
    1226181-2013-00166
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 16, 2013
    Report Date
    March 16, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DETERMINED THAT THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SYSTEM SHOULD BE CLEANED. THE FSE PERFORMED A SYSTEM POWERFLUSH AND THEN CHECKED THE IMT SYSTEM, WHICH WAS WORKING PROPERLY. THE FSE RAN QUALITY CONTROLS AND PERFORMED A PRECISION TEST, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT SODIUM, CHLORIDE, AND POTASSIUM RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT, FALSELY LOW CHLORIDE RESULT, AND FALSELY ELEVATED POTASSIUM RESULT WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION VISTA 1500 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT, AND DIFFERENT VALUES WERE OBTAINED. THE SAMPLE WAS THEN RERUN IN TRIPLICATE ON AN ALTERNATE INSTRUMENT, AND THE RESULTS MATCHED THE RERUN RESULTS FROM THE DIMENSION VISTA 1500. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM, CHLORIDE, AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156714 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 1500

    Patients

    Seq Age Sex Outcome Treatment
    1