BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM

    MDR report key: 3030470 · Received April 2, 2013

    Report

    Report Number
    1226181-2013-00153
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) MODULE AND THE PERISTALTIC PUMP TUBING. THE FSE PERFORMED PRESSURE TESTS, RAN A DILUTION CHECK, WHICH RESULTED WELL. THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION VISTA 500 INSTRUMENT. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON ALTERNATE INSTRUMENTS, AND THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE CUSTOMER THEN RAN PRECISION TESTS ON PATIENT SAMPLES ON THE DIMENSION VISTA 500, AND ONE PRECISION TEST RESULT DID NOT MATCH THE OTHER RESULTS. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134023 DIMENSION VISTA CLINICAL CHEMISTRY SYSTEM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION VISTA 500

    Patients

    Seq Age Sex Outcome Treatment
    1