BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 5177945 · Received October 26, 2015

    Report

    Report Number
    1226181-2015-00608
    Event Type
    Malfunction
    Date Received
    October 26, 2015
    Date of Event
    October 5, 2015
    Report Date
    October 6, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED A SIEMENS CUSTOMER CARE CENTER (CCC) SPECIALIST. THE CUSTOMER OBTAINED A DISCORDANT RESULT ON THE ORIGINAL SAMPLE, WHICH WAS PLASMA. A NEW SERUM SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS REPEATED NORMAL. THE QUALITY CONTROLS WERE WITHIN ACCEPTABLE RANGES. A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST REVIEWED THE INSTRUMENT DATA AND DID NOT FIND AN INSTRUMENT MALFUNCTION. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA, K AND CL RESULTS ON ONE PATIENT SAMPLE 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 ELEVATED SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE SAMPLE WAS RUN IN TRIPLICATE FOR NA AND K AND IT WAS RUN IN DUPLICATE FOR CL. THE FIRST REPLICATES FOR NA, K AND CL RESULTED FALSELY HIGH, WHILE THE FOLLOWING REPLICATES RESULTED LOWER. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). A NEW SAMPLE WAS OBTAINED FROM THE PATIENT AND WAS TESTED ON THE SAME INSTRUMENT IN DUPLICATE AND BOTH REPLICATES RESULTED LOWER FOR NA, K, AND CL. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707503 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1