BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA 1800

    MDR report key: 1971184 · Received January 26, 2011

    Report

    Report Number
    2432235-2011-00004
    Date Received
    January 26, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 4, 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
    MI, 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 PROACTIVELY REPLACED THE DILUTION PROBE PIPETTE AND THE LIQUID LEVEL SENSOR. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE OF THE DISCORDANT TOTAL PROTEIN_2 RESULT IS UNKNOWN. NO CONCLUSIONS CAN BE DRAWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE SYSTEM IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW TOTAL PROTEIN_2 (UPRO_2) RESULTS WERE OBTAINED ON AN ADVIA 1800 FOR ONE (1) CSF SAMPLE. THE CSF SAMPLE WAS CLEAR AFTER CENTRIFUGATION. THE INITIAL VALUE WAS FLAGGED AS HIGH, AND WAS REPEATED TWICE. THE 1ST REPEAT YIELDED A NEGATIVE RESULT. THE 2ND REPEAT YIELDED A LOWER VALUE, WHICH WAS REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULT. THE SAMPLE WAS THEN RE-TESTED ON THE LABORATORY'S OTHER SYSTEM, AND YIELDED A RESULT THAT WAS HIGHER THAN THE INITIAL HIGH RESULT. PATIENT TREATMENT WAS NOT ALTERED OR PRESCRIBED. THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CSF TOTAL PROTEIN 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