BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR

    MDR report key: 1112166 · Received August 5, 2008

    Report

    Report Number
    2432235-2008-00082
    Event Type
    Other
    Date Received
    August 5, 2008
    Date of Event
    June 5, 2008
    Report Date
    June 5, 2008
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 THE WASH 1 SENSOR BEING OUT OF CALIBRATION. 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 POSITIVE ADVIA CENTAUR TROPONIN ULTRA PATIENT RESULT WAS REPORTED TO THE EMERGENCY ROOM PHYSICIAN. UPON RE-TEST ON THE SAME INSTRUMENT, THE TROPONIN RESULT WAS STILL POSITIVE. THE SAME SAMPLE WAS RE-TESTED ON A DIFFERENT INSTRUMENT AND THE TROPONIN RESULT WAS NEGATIVE. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1