BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2301094 · Received October 19, 2011

    Report

    Report Number
    2432235-2011-00147
    Event Type
    Malfunction
    Date Received
    October 19, 2011
    Date of Event
    October 3, 2011
    Report Date
    October 3, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CJY
    PMA / PMN Number
    K990346
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 AND PERFORMING A DIAGNOSTIC TEST, THE FSE CLEANED THE LWP (LARGE WATER PUMP) FILTER AND ADJUSTED THE WATER PRESSURE. THE ACTUAL CAUSE COULD NOT BE DETERMINED, AND NO CONCLUSION CAN BE DRAWN AS TO WHAT CAUSED THE DISCORDANT CALCIUM (CA_2) RESULTS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH CALCIUM (CA_2) RESULTS WERE OBTAINED WITH TWO (2) PATIENT SAMPLES ON AN ADVIA 1800. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN DUE TO THE DELTA CHECKS. THE SAMPLES WERE RETESTED ON THE LABORATORY'S SECOND ADVIA 1800 ANALYZER, AND THE REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CALCIUM RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1