BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1200

    MDR report key: 1970649 · Received January 25, 2011

    Report

    Report Number
    2432235-2011-00014
    Date Received
    January 25, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE DIAGNOSTICS INC. FSE (FIELD SERVICE ENGINEER) WAS DISPATCHED TO THE CUSTOMER SITE FOR INSTRUMENT EVALUATION. THE FSE OBSERVED AIR SLUGS IN THE BUFFER LINE AND REPLACED THE BUFFER VALVE ON THE ISE (ION SELECTIVE ELECTRODE) ASSEMBLY. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH SODIUM (NA) AND CHLORIDE (CL) RESULTS WERE OBTAINED WITH AN UNSPECIFIED NUMBER OF PATIENT SAMPLES ON AN ADVIA 1200. THE DISCORDANT RESULTS WERE REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE PATIENT SAMPLES WERE RE-DRAWN AND RE-TESTED. THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). IT IS UNKNOWN IF PATIENT TREATMENT WAS ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT SODIUM AND CHLORIDE RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1