BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3060781 · Received April 16, 2013

    Report

    Report Number
    1226181-2013-00175
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE QUICKLYTE SENSOR AND THE X-TUBING, WHICH THE CUSTOMER DID. THE TSC SPECIALIST ALSO INSTRUCTED THE CUSTOMER TO PERFORM A SUPERCONDITIONING OF THE INSTRUMENT. THE CUSTOMER THEN RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION EXL WITH LM INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS RERUN ON THE SAME INSTRUMENT, AND RESULTED HIGHER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162479 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1