BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3788016 · Received May 2, 2014

    Report

    Report Number
    1226181-2014-00242
    Event Type
    Malfunction
    Date Received
    May 2, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MZV
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS CUSTOMER CARE CENTER (CCC) WAS CONTACTED BY THE CUSTOMER. THE CCC EVALUATED THE INSTRUMENT DATA AND INSTRUCTED THE CUSTOMER TO CHECK THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) PUMPING RATE AND TO REPLACE THE QUIKLYTE SENSOR. THE CCC RECOMMENDED THAT THE CUSTOMER ENSURE TUBES ARE FULL DRAWS, TO PREVENT PLATELETS FROM FORMING, WHICH CAN CAUSE ELEVATED POTASSIUM RESULTS ON INITIAL ASPIRATION. THE CAUSE OF THE ELEVATED POTASSIUM RESULTS IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN PRECISION AND QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT POTASSIUM (K) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT K RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED IT. THE CUSTOMER RERAN THE SAMPLE (1ST REPEAT) ON THE SAME INSTRUMENT AND THAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE CUSTOMER REPEATED THE SAMPLE LATER THAT DAY (2ND REPEAT) ON THE SAME INSTRUMENT, WHICH RESULTED LOWER. THE SAMPLE WAS ALSO REPEATED (3RD REPEAT) ON AN ALTERNATE SYSTEM, WHICH RESULTED LOWER. THESE RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE PATIENT WAS REDRAWN AND THE SAMPLE WAS TESTED ON AN ALTERNATE SYSTEM, WHICH RESULTED LOWER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT K RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265771 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM MZV SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1