BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 4103670 · Received September 19, 2014

    Report

    Report Number
    1226181-2014-00470
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND DETERMINED THAT DURING THE TIME OF THE EVENT, THE INSTRUMENT GENERATED STANDARD AIR / FLUID DETECTION ERRORS. THE CSE CLEANED SALT FROM THE INTEGRATED MULTISENSOR TECHNOLOGY MODULE SENSOR TOWER FITTINGS AND SALT BRIDGE CAP. THE CSE REPLACED THE ROTARY VALVE ASSEMBLY AND THE X TUBING. THE CAUSE OF THE DISCORDANT SODIUM AND CHLORIDE RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY RAN A PRECISION TEST AND QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT NA AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THEM. THE SAMPLES WERE REPEATED ON AN ALTERNATE INSTRUMENT. THE CORRECTED NA AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582461 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JJE SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1