BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3080008 · Received April 26, 2013

    Report

    Report Number
    2432235-2013-00155
    Event Type
    Malfunction
    Date Received
    April 26, 2013
    Date of Event
    April 1, 2013
    Report Date
    April 2, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CEM
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). DURING TROUBLESHOOTING WITH THE TSC SPECIALIST ADVISED THE CUSTOMER TO REPLACE THE POTASSIUM ELECTRODE, WHICH THE CUSTOMER DID. THE TSC SPECIALIST FOLLOWED UP WITH THE CUSTOMER ABOUT POTASSIUM RESULTS AFTER INSTALLATION OF THE NEW ELECTRODE, AND THE CUSTOMER STATED THAT POTASSIUM RESULTS WERE RESULTING AS EXPECTED. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED POTASSIUM RESULT WAS A MALFUNCTION OF THE ELECTRODE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181311 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER CEM SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1