BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 4411873 · Received January 13, 2015

    Report

    Report Number
    1226181-2015-00027
    Event Type
    Malfunction
    Date Received
    January 13, 2015
    Date of Event
    December 27, 2014
    Report Date
    December 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). A SIEMENS HEADQUARTERS SUPPORT CENTER (HSC) SPECIALIST EVALUATED THE INSTRUMENT DATA AND INSTRUCTED THE CUSTOMER TO REPLACE TUBING AND PERFORM A BACK FLUSH OF THE ROTARY VALVE SEAL. THE HSC ALSO INSTRUCTED THE CUSTOMER TO CHECK AND INCREASE THE PUMP RATE. THE CUSTOMER SUCCESSFULLY RAN QUALITY CONTROLS. THE CAUSE OF THE DISCORDANT POTASSIUM, SODIUM AND CHLORIDE RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY LOW SODIUM (NA), POTASSIUM (K) AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT NA, K AND CL RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON AN ALTERNATE SYSTEM, RESULTING HIGHER. THE REPEATED NA, K AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT NA, K AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29510 DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1