BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 2400

    MDR report key: 3160341 · Received June 10, 2013

    Report

    Report Number
    2432235-2013-00208
    Event Type
    Malfunction
    Date Received
    June 10, 2013
    Date of Event
    May 9, 2013
    Report Date
    May 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL SERVICE CONSULTANT (TSC) WAS CONTACTED BY THE CUSTOMER. THE TSC EVALUATED THE INSTRUMENT DATA AND DETERMINED THAT THE CAUSE FOR THE DISCORDANT SODIUM RESULTS WAS USER ERROR. THE QC WAS OUTSIDE THE INSTRUMENT LIMITS AND SODIUM RESULTS WERE RELEASED FROM THE LAB DURING THIS TIME. THE TSC DIRECTED THE CUSTOMER TO PERFORM ION-SELECTIVE ELECTRODE CALIBRATION AND REPEAT QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM (NA) RESULTS WERE OBTAINED ON AN ADVIA 2400 FOR TWO PATIENTS. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIANS. THE RESULTS WERE REPEATED ON AN ALTERNATE SYSTEM AND THE CORRECTED RESULTS WERE REPORTED TO THE PHYSCIANS. THERE WERE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259809 ADVIA 2400 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 2400

    Patients

    Seq Age Sex Outcome Treatment
    1