BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA 1800

    MDR report key: 3051749 · Received April 10, 2013

    Report

    Report Number
    2432235-2013-00129
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    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 DETERMINED THE CAUSE OF THE DISCORDANT TBIL AND DBIL RESULTS WERE USER ERROR. THE FSE FOUND THE CLOT SENSOR TURNED OFF. THE FSE TURNED THE CLOT SENSOR ON, PERFORMED A TOTAL SERVICE CALL AND RAN QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS FOR TOTAL BILIRUBIN (TBIL) AND DIRECT BILIRUBIN (DBIL) WERE OBTAINED ON AN ADVIA 1800 INSTRUMENT. THE RESULTS WERE REPORTED TO THE PHYSICIAN, WHO QUESTIONED THE RESULTS. THE SAME SAMPLE WAS REPEATED ON THE SAME ANALYZER TWICE. THE CORRECTED RESULTS WERE REPORTED TO THE PHYSICIAN. THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TBIL AND DBIL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148820 ADVIA 1800 CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA 1800

    Patients

    Seq Age Sex Outcome Treatment
    1