BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA 1650

    MDR report key: 1894154 · Received November 4, 2010

    Report

    Report Number
    2432235-2010-00152
    Event Type
    Other
    Date Received
    November 4, 2010
    Date of Event
    October 5, 2010
    Report Date
    October 5, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    JGS
    PMA / PMN Number
    K990346
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CLEANED SALT FROM THE ISE DRAIN, REMOVED AND DRIED ELECTRODES AND REPLACED PERI-TUBING. THE ROOT CAUSE WAS DETERMINED TO BE LACK OF REQUIRED CUSTOMER MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT SODIUM RESULTS WERE OBTAINED FOR TWO PTS ON AN ADVIA 1650. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND CONFIRMED ON AN ALTERNATE ADVIA 1650 INSTRUMENT. THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULTS.

    Additional Manufacturer Narrative · 2

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. AFTER ANALYZING THE INSTRUMENT AND INSTRUMENT DATA, THE FSE CLEANED SALT FROM THE ISE DRAIN, REMOVED AND DRIED ELECTRODES AND REPLACED PERI-TUBING. THE ROOT CAUSE WAS DETERMINED TO BE LACK OF REQUIRED CUSTOMER MAINTENANCE. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 2

    DISCORDANT SODIUM RESULTS WERE OBTAINED FOR TWO PTS ON AN ADVIA 1650. THE RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLES WERE RERUN AND CONFIRMED ON AN ALTERNATE ADVIA 1650 INSTRUMENT. THE CORRECTED RESULTS WERE REPORTED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PT INTERVENTION DUE TO THE DISCORDANT SODIUM RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA 1650 CHEMISTRY ANALYZER JGS SIEMENS HEALTHCARE DIAGNOSTICS, INC ADVIA 1650 NA

    Patients

    Seq Age Sex Outcome Treatment
    1
    2