BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2255811 · Received September 20, 2011

    Report

    Report Number
    2432235-2011-00132
    Event Type
    Malfunction
    Date Received
    September 20, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 2, 2011
    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
    FL, 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. AFTER EVALUATING THE INSTRUMENT, THE FSE DETERMINED THAT A FAULTY SOLENOID WAS CAUSING A DRIP AT THE WUD (REACTION TRAY WASH UNIT). THE FSE REPLACED WUD SOLENOIDS AND THE CDEV1 (REACTION TRAY WASH UNIT DRAIN 1) AND CHECKED THE DWUD (DILUTION TRAY WASH UNIT) AND MIXERS. THE FSE ALSO PERFORMED DIAGNOSTIC TESTS, CALIBRATED THE SYSTEM AND RAN QC. THE QC RESULTS WERE WITHIN RANGE. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT CREATININE AND BUN RESULTS WERE OBTAINED WITH MULTIPLE PATIENT SAMPLES ON AN ADVIA 1800. THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE RETESTED AND THE CORRECTED RESULTS WERE REPORTED OUT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CREATININE AND BUN RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1