BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2180236 · Received July 27, 2011

    Report

    Report Number
    2517506-2011-00123
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 29, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    JGS
    PMA / PMN Number
    K970330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATES THAT THE CAUSE OF 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

    A FALSELY ELEVATE SODIUM RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE SAMPLE WAS REPEATED AND A SIMILAR RESULT WAS OBTAINED. THE RESULT WAS REPORTED TO THE PHYSICIAN. PHYSICIAN SUSPECTED RENAL FAILURE AND MOVED THE PATIENT TO THE EMERGENCY ROOM (ER). ER RESULT ON THE PATIENT WAS NORMAL FOR SODIUM. REPEAT TESTING OF THE ORIGINAL SAMPLE WAS NORMAL FOR SODIUM. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ANY ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE ELEVATED SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM DIMENSION® QUICKLYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS, INC

    Patients

    Seq Age Sex Outcome Treatment
    1