BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3183067 · Received June 21, 2013

    Report

    Report Number
    2432235-2013-00282
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 29, 2013
    Report Date
    May 29, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). DURING TROUBLESHOOTING, THE CUSTOMER REPLACED THE SODIUM ELECTRODE AND INFORMED THE TSC SPECIALIST THAT REPLACING THE SODIUM ELECTRODE HAD RESOLVED THE PROBLEM. THE CAUSE OF THE DISCORDANT SODIUM RESULTS 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 SODIUM RESULTS WERE OBTAINED ON PATIENT SAMPLES ON AN ADVIA 1800 INSTRUMENT. IT IS UNKNOWN IF THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN ON AN ALTERNATE INSTRUMENT, AND DIFFERENT RESULTS WERE OBTAINED. IT IS UNKNOWN IF 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 SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283300 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1