BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 4103052 · Received September 19, 2014

    Report

    Report Number
    2432235-2014-00556
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 25, 2014
    Report Date
    August 26, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE CCC. THE CUSTOMER STATED THAT THEY HAD REPLACED THE SODIUM ELECTRODE, WHICH RESOLVED THE ISSUE. THE CAUSE OF THE DISCORDANT SODIUM RESULTS WAS AN ELECTRODE MALFUNCTION. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED THE SIEMENS CUSTOMER CARE CENTER (CCC) AND STATED THAT SODIUM RESULTS FOR PATIENT SAMPLES TESTED ON AN ADVIA 1800 INSTRUMENT WERE LOWER THAN EXPECTED. THE CUSTOMER STATED THAT APPROXIMATELY FOUR-HUNDRED PATIENT SAMPLES HAD BEEN TESTED. THE CUSTOMER INFORMED PHYSICIAN(S) THE SODIUM METHOD WAS RUNNING LOW, BUT DID NOT ISSUE CORRECTED REPORTS. THERE ARE NO 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
    582587 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1