BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL 200

    MDR report key: 4382218 · Received January 5, 2015

    Report

    Report Number
    1226181-2015-00006
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    December 10, 2014
    Report Date
    December 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JJE
    PMA / PMN Number
    K073604
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC INSTRUCTED THE CUSTOMER TO RUN A QUALITY CONTROLS PRECISION STUDY, AND ALL RESULTS WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW NA, K AND CL RESULTS IS UNKNOWN, AS THE SAMPLE RESULTED AS EXPECTED UPON REPEAT TESTING ON THE SAME INSTRUMENT.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 EXL 200 INSTRUMENT. ONLY THE DISCORDANT K AND CL RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS AUTO-REPEATED ON THE SAME INSTRUMENT, RESULTING HIGHER FOR ALL ASSAYS. THE SAMPLE WAS THEN REPEATED ON THE SAME INSTRUMENT AND ON AN ALTERNATE DIMENSION INSTRUMENT, WHICH MATCHED THE AUTO-REPEAT RESULT. THE CORRECTED 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
    2690 DIMENSION EXL 200 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL 200

    Patients

    Seq Age Sex Outcome Treatment
    1