BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2231774 · Received September 1, 2011

    Report

    Report Number
    2517506-2011-00132
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 12, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SODIUM RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED ELECTROLYTE RESULTS FOR SODIUM (NA) WERE OBTAINED ON TWO CONSECUTIVE PATIENT SAMPLES. THE NA RESULTS WERE ABOVE NORMAL REFERENCE RANGES. THE RESULTS WERE REPORTED TO THE PHYSICIAN. THE LAB RECOGNIZED THE TREND AND IMMEDIATELY RERAN THE SAMPLES ON AN ALTERNATE VISTA(R) ANALYZER TO CONFIRM THE RESULTS. THE RESULTS OBTAINED WERE LOWER (NA NOW WITHIN REFERENCE RANGES) AND CORRECTED RESULTS WERE REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM V-LYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 1CD859

    Patients

    Seq Age Sex Outcome Treatment
    1