BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 2012373 · Received March 9, 2011

    Report

    Report Number
    1219913-2011-00027
    Date Received
    March 9, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND PERFORMED GENERAL SYSTEM MAINTENANCE. ANALYSIS OF THE SYSTEM DATA AND QC INDICATE THAT THERE ARE NO KNOWN SYSTEM ISSUES THAT MAY HAVE CONTRIBUTED TO THE DISCORDANT FALSE POSITIVE ADVIA CENTAUR XP TROPONIN TEST RESULT. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED ON AN EMERGENCY ROOM PATIENT AND REPORTED TO THE PHYSICIAN. THE RESULT WAS DISCORDANT WHEN COMPARED TO NEGATIVE FOLLOW UP AND REPEAT TROPONIN TEST RESULTS. THE PATIENT WAS ADMINISTERED AN IV NITRO DRIP AND A CORRECTED RESULT WAS PROVIDED TO THE PHYSICIAN BY THE CUSTOMER. THERE WAS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 051

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR