BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1082575 · Received July 21, 2008

    Report

    Report Number
    2432235-2008-00081
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    June 17, 2008
    Report Date
    June 17, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT RESULT WAS DUE TO A LOOSE STRAW IN THE BASE BULK CONTAINER. 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

    A DISCORDANT HIGH RESULT WAS OBTAINED FOR TROPONIN ON ONE PATIENT SAMPLE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED AS REQUESTED BY THE PHYSICIAN AND THE REPEATED RESULT WAS DIFFERENT THAN THE REPORTED RESULT. PATIENT TREATMENT WAS ALTERED DUE TO THE DISCORDANT TROPONIN RESULT AS FOLLOWS: A CARDIAC CATHETERIZATION WAS PERFORMED ON THE PATIENT.

    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