BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    MDR report key: 1131823 · Received August 22, 2008

    Report

    Report Number
    2517506-2008-00076
    Event Type
    Death
    Date Received
    August 22, 2008
    Date of Event
    July 31, 2008
    Report Date
    July 31, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JJE
    PMA / PMN Number
    K970330
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE FAILURE OCCURRED. THE INSTRUMENT IS PERFORMING WITHIN SPECS. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE FALSELY ELEVATED SODIUM RESULT WAS USER ERROR. THE OPERATOR USED REAGENT PROBE CLEANER INSTEAD OF IMT SAMPLE PROBE CLEANER. ALL PT SAMPLES AND CONTROLS WERE RUNNING 200-557 MMOL/L. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY ELEVATED SODIUM RESULT OF 209 MMOL/L WAS OBTAINED ON A PT SAMPLE. THE RESULT WAS REPORTED TO THE PHYSICIAN. THE PT WAS TREATED WITH A NORMAL SALINE IV AND LATER EXPIRED FROM A GI BLEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIMENSION CLINICAL CHEMISTRY SYSTEM QUIKLYTE INTEGRATED MULTISENSOR JJE SIEMENS HEALTHCARE DIAGNOSTICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Death