BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2622248 · Received June 20, 2012

    Report

    Report Number
    2432235-2012-00190
    Event Type
    Malfunction
    Date Received
    June 20, 2012
    Date of Event
    May 21, 2012
    Report Date
    May 21, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    CGZ
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO EVALUATE THE ADVIA 1800 INSTRUMENT. THE CUSTOMER REPLACED THE CHLORIDE (CL-) ELECTRODE IN AN ATTEMPT TO RESOLVE THE PROBLEM PRIOR TO THE FSE EVALUATING THE INSTRUMENT. THE FSE CHECKED THE ION SELECTIVE ELECTRODE (ISE) AND THE PERCENT CV, VERIFIED THAT THE PRECISION WAS WITHIN RANGE, AND CALIBRATED THE INSTRUMENT. THE QUALITY CONTROL WAS IN RANGE. THE CAUSE OF THE DISCORDANT CHLORIDE PATIENT RESULTS IS UNKNOWN. THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    SEVERAL DISCORDANT, FALSELY ELEVATED, CHLORIDE (CL-) RESULTS WERE OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE DISCORDANT RESULTS WERE REPORTED TO PHYSICIAN(S), WHO QUESTIONED THE RESULTS. THE SAMPLES WERE RERUN, AND THE CORRECTED RESULTS WERE REPORTED TO PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES OR PATIENT INTERVENTION DUE TO THE DISCORDANT, FALSELY ELEVATED CHLORIDE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1800 CHEMISTRY ANALYZER CGZ SIEMENS HEALTHCARE DIAGNOSTICS ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1