BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1082562 · Received July 21, 2008

    Report

    Report Number
    2432235-2008-00089
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND DISCORDANT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULTS APPEARS TO HAVE BEEN DUE TO DEPLETION OF WASH 1 FLUID. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT RESULTS WERE OBTAINED FOR TROPONIN ON THREE PATIENT SAMPLES. THE DISCORDANT'S RESULTS WERE REPORTED TO THE PHYSICIAN. THE SAMPLES WERE REPEATED AND THE REPEATED RESULTS WERE DIFFERENT THAN THE REPORTED RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR IMMUNO-ASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1