BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1800

    MDR report key: 2062773 · Received April 19, 2011

    Report

    Report Number
    2432235-2011-00055
    Date Received
    April 19, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 21, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT DATA, THE FSE DETERMINED THAT THE CAUSE OF THE DISCORDANT POTASSIUM RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT POTASSIUM RESULT WAS OBTAINED FOR ONE PATIENT SAMPLE. THE SAMPLE WAS RE-TESTED ON THE SAME ANALYZER AND NORMAL RESULTS WERE OBTAINED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT POTASSIUM RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1