BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3013723 · Received March 20, 2013

    Report

    Report Number
    1226181-2013-00133
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 21, 2013
    Report Date
    February 21, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS TECHNICAL SUPPORT CENTER (TSC) ANALYZED THE INSTRUMENT DATA AND DETERMINED THE CUSTOMER WAS GETTING RANDOM AIR/FLUID DETECT ERRORS. THE CAUSE OF THE DISCORDANT SODIUM RESULTS WAS A LEAK IN THE INTEGRATED MULTI-SENSOR TECHNOLOGY (IMT) SENSOR. SIEMENS INSTRUCTED THE CUSTOMER TO REPLACE THE IMT SENSOR AND RUN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA) RESULTS WERE OBTAINED ON A DIMENSION EXL WITH LM INSTRUMENT FOR TWO PATIENTS. THE INITIAL RESULTS WERE NOT REPORTED TO THE PHYSICIANS. THE SAMPLES WERE RETESTED AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115223 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1