BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3062565 · Received April 17, 2013

    Report

    Report Number
    1226181-2013-00177
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    March 24, 2013
    Report Date
    March 24, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    JGS
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED (B)(4). AFTER EVALUATION OF THE INSTRUMENT DATA, THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE INTEGRATED MULTISENSOR TECHNOLOGY SENSOR, REALIGN THE SAMPLE PROBE, AND RUN A SYSTEM CONDITIONING. THE CUSTOMER DID SO, AND THEN RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. PRECISION STUDIES WERE PERFORMED ON THE PATIENT SAMPLES THAT DISCORDANT RESULTS HAD BEEN OBTAINED ON. ALL SAMPLES RESULTED AS EXPECTED AND THE PRECISION RESULTS WERE WITHIN SPECIFICATIONS. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULTS IS UNKNOWN. THE 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. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE OPERATOR RERAN THE SAMPLES ON THE SAME INSTRUMENT AND THE ANION GAP RESULTS CHANGED FOR THE THREE PATIENTS. THE OPERATOR THEN DISCOVERED THAT SODIUM HAD RESULTED HIGHER UPON RERUN. THE RERUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164542 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1