BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY

    MDR report key: 3940552 · Received July 17, 2014

    Report

    Report Number
    1219913-2014-00181
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Date of Event
    June 29, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULT IS UNKNOWN. THE CUSTOMER CALIBRATES EVERY READYPACK OF TROPONIN. THE CUSTOMER DID NOT OBSERVE ANY ANOMALIES IN THE PHYSICAL APPEARANCE OF THE REAGENTS. QUALITY CONTROL MATERIAL RESULTS ARE WITHIN SPECIFICATION. CLOTTING TIME FOR SAMPLES VARIES BETWEEN 10 MINUTES AND 1 HOUR. SAMPLES ARE CENTRIFUGED AT 4000 RPMS FOR 7 MINUTES BEFORE ENTRY ONTO AUTOMATION SAMPLE MANAGER. THE WERE NO OTHER REPORTS OF NON-REPRODUCIBLE RESULTS ON THIS INSTRUMENT ON THIS DAY. THE INSTRUCTIONS 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

    CUSTOMER OBSERVED AN ELEVATED NON-REPRODUCIBLE ADVIA CENTAUR XP TROPONIN ULTRA RESULT. THE CUSTOMER REPEATS EVERY SAMPLE WITH A RESULT LESS THAN 20 NG/L ON THE SAME ANALYZER INITIALLY AND THEN ON THE SECOND ADVIA CENTAUR XP FOR CONFIRMATION PRIOR TO RELEASE OF THE RESULT FROM THE LAB. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED. THERE ARE NO REPORTS OR ADVERSE HEALTH CONSEQUENCES BASED ON THE ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418875 ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010084

    Patients

    Seq Age Sex Outcome Treatment
    1