BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 1972532 · Received December 30, 2010

    Report

    Report Number
    2432235-2010-00196
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 14, 2010
    Report Date
    December 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGZ
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATED THAT THE CAUSE OF THE DISCORDANT SODIUM AND POTASSIUM RESULTS WAS DUE TO THE ISE BUFFER SOLUTION TUBING WHICH WAS DAMAGED. THE FSE REPLACED THE ISE BUFFER TUBING. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA 1800 SODIUM AND POTASSIUM RESULTS WERE OBTAINED ON PT SAMPLES. THE RESULTS WERE REPORTED TO THE HEALTHCARE PROVIDER(S). THE PT SAMPLES WERE REPEATED ON THE SAME ADVIA 1800 SYSTEM AND THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT SODIUM AND POTASSIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER CGZ SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1800 NA

    Patients

    Seq Age Sex Outcome Treatment
    1