BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 6356254 · Received February 24, 2017

    Report

    Report Number
    2517506-2017-00210
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    February 4, 2017
    Report Date
    February 24, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. WHILE EVALUATING THE INSTRUMENT, THE CSE CHECKED THE PUMP RATE AND THE INTEGRATED MULTI-SENSOR TECHNOLOGY (IMT) SENSOR. THE IMT SENSOR WAS NEAR EXPIRY. THE CSE REPLACED ALL IMT PUMP TUBING AND PRESSURE TOWER. THE CSE REPLACED THE SALT BRIDGE AND FLUSH SOLUTION. THE CSE REPLACED THE OLD SENSOR LOT WITH A NEW ONE. THE CSE RAN CONDITIONING AND DILUTION CHECK TWICE. THE CSE RAN CALIBRATION, WHICH PASSED. THE CSE RAN SYSTEM CHECK, RESULTING SATISFACTORY. THE CUSTOMER RAN ELECTROLYTES QUALITY CONTROLS (QC), RESULTING WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT FALSELY, LOW CL, K AND NA RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW CHLORIDE (CL) RESULT WAS OBTAINED ON A PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE DIMENSION EXL INSTRUMENT, RESULTING HIGHER. THE REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER STATED DISCORDANT RESULTS FOR SODIUM (NA) AND POTASSIUM (K) FLAGGED AS CRITICALLY LOW WERE OBTAINED ON A COUPLE OF PATIENT SAMPLES ON THE DIMENSION EXL WITH LM INSTRUMENT. FOR ONE PATIENT, THE RESULTS WERE REPORTED AND A COMPUTERIZED AXIAL TOMOGRAPHY (CT) SCAN WAS ORDERED FOR THE PATIENT(S). THE SAMPLE WAS REPEATED AND RESULTED NORMAL. NO RESULTS WERE PROVIDED FOR NA AND K FOR THE PATIENT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW CL AND CRITICALLY LOW NA AND K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138173 DIMENSION EXL WITH LM DIMENSION EXL WITH LM JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1