BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1200

    MDR report key: 1971929 · Received January 27, 2011

    Report

    Report Number
    2432235-2011-00003
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 29, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K990346
    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 BUBBLES IN THE BUFFER LINE, AND REPLACED THE BUFFER VALVE AND STIRRER. AFTER REPLACEMENT OF THE VALVE AND STIRRER, NO MORE BUBBLES WERE OBSERVED. THE FSE CALIBRATED THE SYSTEM AND RAN QUALITY CONTROL SAMPLES. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    INTERMITTENT DISCORDANT HIGH SODIUM (NA) RESULTS WERE OBTAINED WITH SIX (6) PATIENT SAMPLES ON AN ADVIA 1200. INTERMITTENT DISCORDANT HIGH CHLORIDE (CL) RESULTS WERE ALSO OBTAINED WITH FIVE (5) OF THE SAME SIX (6) PATIENT SAMPLES ON AN ADVIA 1200. INITIALLY, DISCORDANT NA AND CL RESULTS FOR ONE (1) PATIENT WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE PHYSICIAN'S QUESTIONING OF THE RESULTS PROMPTED THE LABORATORY TO REPEAT NA TESTING ON THOSE PATIENTS WITH NA RESULTS OF >150 MEQ/L, AND TO REPEAT CL TESTING FOR THOSE WITH CL RESULTS OF >110 MEQ/L.. 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