BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BAYER ADVIA CENTAUR IMMUNOASSAY SYSTEM

    MDR report key: 879753 · Received June 19, 2007

    Report

    Report Number
    879753
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    May 4, 2007
    Report Date
    June 13, 2007
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JJE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN, US

    Narratives

    Description of Event or Problem · 1

    INCORRECT TROPONIN RESULTS WERE REPORTED ON TWO PATIENTS. 1) POOR INSTRUMENT PRECISION ON BAYER CENTAUR RESULTED IN AN INCORRECT TROPONIN TO BE RELEASED ON THE PATIENT. THE FLOOR WAS NOTIFIED OF THE INCORRECT RESULT. NOTHING WAS DONE TO THE PATIENT AS A RESULT OF THE INCORRECT RESULT. THE RESULT WAS CHANGED IN THE COMPUTER WITH A NOTE OF EXPLANATION. 2) AN INCORRECT RESULT FOR TROPONIN WAS RELEASED DUE TO BAYER CENTAUR INSTRUMENT POOR PRECISION. THE PATIENT HAD A PREVIOUS POSITIVE RESULT. NOTHING WAS DONE TO THE PATIENT AS A RESULT OF THE INCORRECT TROPONIN RESULT. THE RESULT WAS CHANGED IN THE COMPUTER WITH A NOTE OF EXPLANATION. SIEMENS IS CURRENTLY WORKING ON THIS ISSUE WITH US. RESULTS BETWEEN 0.08 AND 0.50 ARE BEING REPEATED. IF THE RESULT IS WITHIN 50% OF THE PREVIOUS AND WITHIN 12 HOURS OF THE LAST RESULT IT RELEASES AUTOMATICALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BAYER ADVIA CENTAUR IMMUNOASSAY SYSTEM ANALYZER, CHEMISTRY JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR
    2 61 YR