BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3855045 · Received June 9, 2014

    Report

    Report Number
    2432235-2014-00358
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    May 11, 2014
    Report Date
    May 13, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA. AFTER INSTRUMENT EVALUATION, THE CSE REPLACED THE ION SELECTIVE ELECTRODE MOTOR AND THE SODIUM ELECTRODE. THE CSE ALSO CHECKED INSTRUMENT SENSORS, O-RINGS AND ALIGNMENTS. THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY PERFORMED CALIBRATIONS AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSELY ELEVATED SODIUM RESULTS WERE OBTAINED ON THREE PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT SODIUM RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE REPEATED ON AN ALTERNATE SYSTEM AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335524 ADVIA 1800 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1