BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1082573 · Received July 21, 2008

    Report

    Report Number
    2432235-2008-00083
    Event Type
    Other
    Date Received
    July 21, 2008
    Date of Event
    May 28, 2008
    Report Date
    June 11, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS SENT TO THE CUSTOMER SITE WHEN SIEMENS WAS NOTIFIED OF THE EVENT. THE FIELD SERVICE ENGINEER WAS UNABLE TO DETERMINE THE CAUSE OF THE DISCORDANT RESULT, DUE TO THE CUSTOMER REPORTING THE EVENT TWO WEEKS AFTER THE DATE THAT THE EVENT OCCURRED. THE INSTRUMENT PERFORMING AS SPECIFIED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT RESULT WAS OBTAINED FOR TROPONIN ON ONE PATIENT SAMPLE. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT ALTERED DUE TO THE DISCORDANT TROPONIN RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1