BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION® CLINICAL CHEMISTRY SYSTEM

    MDR report key: 2100288 · Received May 24, 2011

    Report

    Report Number
    2517506-2011-00099
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 12, 2011
    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 DEPRESSED SODIUM RESULTS WAS SAMPLE INTEGRITY. THE QUIKLYTE(R) INTEGRATED MULTISENSOR INSTRUCTIONS FOR USE STATES: "FOLLOW THE INSTRUCTIONS WITH YOUR SPECIMEN COLLECTION DEVICE FOR COLLECTION, TUBE HANDLING, SPIN TIMES, AND G-FORCE ESPECIALLY WHEN USING PLASTIC BLOOD COLLECTION TUBES. 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 DEPRESSED SODIUM (NA) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE RESULT WAS WERE REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. THE SAMPLE WAS REPEATED ON AN ALTERNATE INSTRUMENT AND HIGHER RESULTS WITHIN THE NORMAL RANGE WERE OBTAINED AND REPORTED. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES AS A RESULT OF THE FALSELY DEPRESSED SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION® CLINICAL CHEMISTRY SYSTEM QUIKLYTE® INTEGRATED MULTISENSOR JGS SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW 1BD853

    Patients

    Seq Age Sex Outcome Treatment
    1