BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2231776 · Received September 1, 2011

    Report

    Report Number
    2517506-2011-00133
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 17, 2011
    Report Date
    August 17, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY DEPRESSED SODIUM RESULTS IS USER ERROR. THE CUSTOMER FAILED TO APPLY THE APPROPRIATE DILUTION FACTOR TO THE RESULT CALCULATION FOR MANUALLY DILUTED SAMPLES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY DEPRESSED ELECTROLYTE RESULTS FOR SODIUM (NA) WERE OBTAINED ON TWO PATIENT SAMPLE WITHIN THE SAME WORKDAY. BOTH SAMPLES WERE TREATED WITH A DILUENT TO OVERCOME SAMPLE LIPEMIA. THE RESULTS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULTS. USER ERROR WAS RECOGNIZED AND AFTER A CORRECT DILUTION FACTOR WAS APPLIED, THE SAMPLES WERE RERUN. HIGHER RESULTS WERE THEN OBTAINED AND CORRECTED RESULTS REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED 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 1CD864

    Patients

    Seq Age Sex Outcome Treatment
    1