BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3936240 · Received July 15, 2014

    Report

    Report Number
    2432235-2014-00412
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    June 20, 2014
    Report Date
    June 20, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE REMOVED THE ELECTRODES TO CLEAN THE HOLDER AND TIGHTENED ALL CONNECTIONS. QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED NA RESULT 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

    A DISCORDANT, FALSELY ELEVATED SODIUM (NA) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED THREE TIMES ON THE SAME INSTRUMENT, RESULTING LOWER. IT IS UNKNOWN IF THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED NA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412819 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1