BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIMENSION EXL WITH LM

    MDR report key: 3974166 · Received August 1, 2014

    Report

    Report Number
    1226181-2014-00406
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC
    Product Code
    JGS
    PMA / PMN Number
    K130276
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC). CCC INSTRUCTED THE CUSTOMER TO BLEACH THE WASTE LINE AND PURGE IT WITH WATER. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULTS IS UNKNOWN, AS THE SAMPLES 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

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER TO REPORT TWO DISCORDANT, FALSELY LOW SODIUM (NA) RESULTS THAT HAD BEEN OBTAINED ON TWO PATIENT SAMPLES ON A DIMENSION EXL WITH LM INSTRUMENT DURING SEPARATE TEST RUNS. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED IN DUPLICATE ON THE SAME INSTRUMENT, RESULTING HIGHER. 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 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451707 DIMENSION EXL WITH LM CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC DIMENSION EXL WITH LM

    Patients

    Seq Age Sex Outcome Treatment
    1