BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 4101212 · Received September 19, 2014

    Report

    Report Number
    1219913-2014-00228
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 27, 2014
    Report Date
    August 28, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. THE FSE PERFORMED PROBE ALIGNMENTS AND VERIFIED FLUIDICS; REMOVED AND CLEANED THE LUMINOMETER; AND PERFORMED THE 12 MONTH PM ON THE SAME SERVICE VISIT. NO ISSUES WERE IDENTIFIED. THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLING IS RECOMMENDED TO DETECT THE TEMPORAL RISE AND FALL OF TROPONIN LEVELS CHARACTERISTIC OF MI. IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF CTNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE CTNI RESULT. AN ELEVATED TROPONIN ALONE IS NOT SUFFICIENT TO MAKE THE DIAGNOSIS OF MI. OTHER MARKERS, SUCH AS CK-MB AND MYOGLOBIN, CAN BE USED IN CONJUNCTION WITH CTNI RESULTS IN AIDING THE DIAGNOSIS OF MI."

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED FOR A PATIENT SAMPLE. THE RESULT WAS RELEASED AND QUESTIONED BY THE EMERGENCY ROOM (ER). THE SAME SAMPLE TUBE WAS REPEATED ON THE ADVIA CENTAUR CP AND THE ADVIA CENTAUR XP. THE RESULTS WERE NEGATIVE. ANOTHER SAMPLE TUBE FROM THE SAME DRAW WAS TESTED ON THE ADVIA CENTAUR CP AND THE ADVIA CENTAUR XP. THE RESULTS WERE NEGATIVE. HEPARIN DRIP WAS ADMINISTERED TO THE PATIENT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582454 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010087

    Patients

    Seq Age Sex Outcome Treatment
    1