BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION VISTA® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2840305 · Received November 20, 2012

    Report

    Report Number
    2517506-2012-00335
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 24, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    CEM
    PMA / PMN Number
    K051087
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 POTASSIUM RESULT IS SAMPLE INTEGRITY. SINCE THE NA AND CL RESULTS WERE NOT IMPACTED, THE INTEGRATED MULTISENSOR (IMT) DILUTION WAS MADE PROPERLY AND SUGGESTS THE SAMPLE WAS OF POOR QUALITY CONTAINING PLATELETS THAT RESULTED IN A FALSELY ELEVATED POTASSIUM RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED POTASSIUM (K) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED ON THE SAME ANALYZER AND A LOWER RESULT WAS OBTAINED. IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED POTASSIUM RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1