BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION(R) CHEMISTRY SYSTEM

    MDR report key: 2010987 · Received March 8, 2011

    Report

    Report Number
    2517506-2011-00038
    Event Type
    Malfunction
    Date Received
    March 8, 2011
    Date of Event
    February 22, 2011
    Report Date
    February 24, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW
    Product Code
    JGS
    PMA / PMN Number
    K970330
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 RESULT IS SAMPLE INTEGRITY. THE IFU FOR THE DIMENSION(R) QUIKLYTE(R) INTEGRATED MULTISENSOR CONTAINS THE FOLLOWING INFORMATION: "FAILURE TO FOLLOW THE BLOOD COLLECTION TUBE INSTRUCTIONS MAY RESULT IN INCREASED MAINTENANCE OR TROUBLESHOOTING OF THE IMT SYSTEM." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AND A CORRECTED RESULT WAS OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY ELEVATED NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION(R) CHEMISTRY SYSTEM DIMENSION(R) QUIKLYTE(R) INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 0LD833

    Patients

    Seq Age Sex Outcome Treatment
    1