BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL W/LM

    MDR report key: 4182112 · Received October 17, 2014

    Report

    Report Number
    1226181-2014-00526
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). DURING TROUBLESHOOTING, THE CUSTOMER MIXED THE BAGS OF STANDARD SOLUTIONS AND REPLACED THE INTEGRATED MULTISENSOR TECHNOLOGY (IMT) SENSOR. THE CAUSE OF THE DISCORDANT SODIUM AND CHLORIDE RESULTS IS UNKNOWN. THIS INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT. OF THE THREE PATIENT SAMPLES, TWO ALSO RESULTED FALSELY LOW FOR CHLORIDE. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE REPEATED ON AN THE SAME INSTRUMENT AND RESULTS WERE HIGHER. IT IS UNKNOWN IF THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM AND CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660037 DIMENSION EXL W/LM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. DIMENSION EXL W/LM

    Patients

    Seq Age Sex Outcome Treatment
    1