BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3191494 · Received June 26, 2013

    Report

    Report Number
    2432235-2013-00287
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    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 TECHNICAL SOLUTIONS CENTER (TSC). THE CUSTOMER STATED THAT THEY HAD REMOVED AND CLEANED ELECTRODES AND PERFORMED ROUTINE MAINTENANCE. THEY RAN QUALITY CONTROLS (QC) AND RAN COMPARISON RESULTS ON AN ALTERNATE INSTRUMENT. QC WAS IN RANGE AND ALL RESULTS MATCHED. THE CAUSE OF THE DISCORDANT, FALSELY LOW SODIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW SODIUM RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA 1800 INSTRUMENT. THE RESULT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT AND THE PATIENT SAMPLE WAS REPEATED ON ANOTHER ADVIA 1800 INSTRUMENT AND RESULTED HIGHER. 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 LOW SODIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291313 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1