BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION XPAND PLUS WITH HM

    MDR report key: 4838715 · Received June 11, 2015

    Report

    Report Number
    1226181-2015-00362
    Event Type
    Malfunction
    Date Received
    June 11, 2015
    Date of Event
    May 20, 2015
    Report Date
    May 20, 2015
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K112999
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC RECOMMENDED THE CUSTOMER TO PERFORM PRECISION TESTING, WHICH RESULTED WITH GOOD REPRODUCIBILITY. QUALITY CONTROLS WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, K, AND CL 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 (NA), POTASSIUM (K), AND CHLORIDE (CL) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON A DIMENSION XPAND PLUS WITH HM INSTRUMENT. THE SAMPLE RESULTED AS EXPECTED UPON INITIAL RUN EXCEPT FOR THE NA RESULT, WHICH WAS FALSELY LOW. THE SAMPLE WAS AUTOMATICALLY REPEATED ON THE SAME INSTRUMENT, RESULTING DISCORDANTLY LOW FOR NA, K, AND CL. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS AUTOMATICALLY REPEATED A SECOND TIME, RESULTING HIGHER. THE SAMPLE WAS THEN MANUALLY RE-RUN ON THE SAME INSTRUMENT, RESULTING HIGHER AND MATCHING THE RESULTS OF THE SECOND REPEAT. THE RE-RUN RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY LOW NA, K, AND CL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381551 DIMENSION XPAND PLUS WITH HM CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION XPAND PLUS WITH HM

    Patients

    Seq Age Sex Outcome Treatment
    1