BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1200

    MDR report key: 3831268 · Received May 23, 2014

    Report

    Report Number
    2432235-2014-00344
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 1, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. AFTER INSTRUMENT AND INSTRUMENT DATA EVALUATION, THE CSE ADJUSTED THE ION SELECTIVE ELECTRODE (ISE) MIXER MOTOR AND REPAIRED THE ISE MODULE. THE CUSTOMER REPLACED THE SODIUM ELECTRODE PRIOR TO THE CSE SITE EVALUATION. THE CAUSE OF THE DISCORDANT SODIUM RESULTS IS UNKNOWN. THE CSE SUCCESSFULLY PERFORMED A SYSTEM PREVENTIVE MAINTENANCE. 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 THREE STAT SAMPLES ON AN ADVIA 1200 INSTRUMENT. THE DISCORDANT SODIUM RESULTS WERE REPORTED TO THE PHYSICIAN(S). TWO PATIENT RESULTS WERE QUESTIONED BY THE PHYSICIAN(S). ONE PATIENT WAS TREATED WITH IV FLUIDS. A SECOND PATIENT WAS REDRAWN AND RETESTED PRIOR TO TREATMENT. THE SAMPLES WERE REPEATED AND REDRAWN, ALL RESULTING LOWER. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308811 ADVIA 1200 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1200

    Patients

    Seq Age Sex Outcome Treatment
    1