BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 5227009 · Received November 16, 2015

    Report

    Report Number
    1226181-2015-00630
    Event Type
    Malfunction
    Date Received
    November 16, 2015
    Date of Event
    September 21, 2015
    Report Date
    October 22, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 AND INSTRUMENT DATA, THE CSE REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) TUBING. UPON FOLLOW-UP, THE CUSTOMER STATED THAT THERE WERE NO FURTHER ISSUES. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, K, AND CL RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT LOW RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). HIGHER RESULTS WERE OBTAINED WHEN TESTED ON THE SAME INSTRUMENT AND AN ALTERNATE DIMENSION EXL INSTRUMENT. THE HIGHER RESULTS OBTAINED WERE REPORTED AS CORRECT TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NA, K, AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755202 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1