BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 2802681 · Received October 24, 2012

    Report

    Report Number
    2432235-2012-00357
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 27, 2012
    Report Date
    September 28, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LCD
    PMA / PMN Number
    K990346
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE FSE ANALYZED THE INSTRUMENT AND THE DATA BASE AND RAN 10 SAMPLES FOR PRECISION WITH VERY GOOD RESULTS. CALIBRATION AND QUALITY CONTROL (QC) WERE IN RANGE. THE CAUSE OF THE DISCORDANT GENTAMICIN RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    TWO DISCORDANT RESULTS FOR GENTAMICIN WERE OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE RESULTS WERE REPORTED OUT AND QUESTIONED BY THE PHYSICIANS. THE SAME SAMPLES WERE REPEATED ON THE SAME INSTRUMENT. LOWER RESULTS WERE OBTAINED AND CORRECTED RESULTS WERE REPORTED TO THE PHYSICIANS. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT GENTAMICIN RESULTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1