BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL W/ LM

    MDR report key: 3222540 · Received July 12, 2013

    Report

    Report Number
    1226181-2013-00316
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SENSOR, ADJUSTED THE PUMP RATE, AND CLEANED THE SAMPLE PROBE AND SAMPLE DRAIN. QUALITY CONTROLS WERE THEN RUN AND WERE IN RANGE. THE FSE ALSO DISCOVERED THAT THE CENTRIFUGE TYPE WAS STAT-SPIN, WHICH IS AGAINST TUBE VENDOR SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULT IS UNKNOWN. THE USAGE OF A STAT-SPIN CENTRIFUGE AGAINST TUBE VENDOR SPECIFICATIONS WAS FAILURE TO FOLLOW INSTRUCTIONS. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE ON A DIMENSION EXL W/ LM INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAME SAMPLE WAS THEN RERUN ON ANOTHER ANALYZER AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322915 DIMENSION EXL W/ LM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL W/ LM

    Patients

    Seq Age Sex Outcome Treatment
    1