BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 3051714 · Received April 10, 2013

    Report

    Report Number
    1226181-2013-00161
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K944093
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. AFTER ANALYZING THE DATA, THE TSC DETERMINED THAT THE CAUSE OF THE DISCORDANT SODIUM AND POTASSIUM RESULTS WAS USER ERROR; SAMPLE RELATED. TUBES SHOULD BE ALLOWED TO CLOT FOR 30 MINUTES TO ENSURE COMPLETE CLOT FORMATION. THE CUSTOMER WAS ONLY LETTING SAMPLES SIT FOR 10 MINUTES TO CLOT. THE CUSTOMER WAS REMINDED OF THE PROPER PROCESS TO ENSURE COMPLETE CLOT FORMATION AND REMINDED TO MAKE SURE TUBES ARE FULL DRAWS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM AND POTASSIUM RESULTS WERE GENERATED BY THE DIMENSION EXL 200 ON ONE PATIENT. THE RESULTS WERE RELEASED FROM THE LABORATORY. THE SAMPLE WAS REPEATED AND THE CORRECTED RESULTS WERE RELEASED TO THE PHYSICIAN. A SECOND SAMPLE WAS DRAWN FROM THE SAME PATIENT AND THOSE RESULTS WERE RELEASED TO THE PHYSICIAN. THE PATIENTS SALINE DRIP WAS CHANGED FROM 0.9 TO 0.45 BASED ON THE ELEVATED SODIUM RESULT FROM THE SECOND SAMPLE. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153934 DIMENSION EXL 200 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1