BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL W/LM

    MDR report key: 4182097 · Received October 17, 2014

    Report

    Report Number
    1226181-2014-00525
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT, THE CSE REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) VALVE ASSEMBLY, IMT METERING SYRINGE, PUMP MOTOR AND SCREW, AND THE SAMPLER PUMP ASSEMBLY. THE CSE ALSO REPLACED AND ADJUSTED THE SAMPLE METERING SYRINGE AND PRIMED ALL PUMPS. A SYSTEM CHECK AND A DILUENT CHECK WERE RUN AND PASSED. THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE CUSTOMER RERAN THE SAMPLE ON AN ALTERNATE INSTRUMENT AND IT RESULTED HIGHER. THE SAMPLE WAS THEN REPEATED ON THE ORIGINAL INSTRUMENT, RESULTING FALSELY LOW AGAIN. THE SAMPLE WAS REPEATED A SECOND TIME ON THE ALTERNATE INSTRUMENT AND RESULTED HIGHER. THE REPEAT RESULTS FROM THE ALTERNATE INSTRUMENT ALIGNED WITH PREVIOUS RESULTS OBTAINED ON THAT PATIENT. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660754 DIMENSION EXL W/LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL W/LM

    Patients

    Seq Age Sex Outcome Treatment
    1