BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) ASSAY

    MDR report key: 3913595 · Received July 3, 2014

    Report

    Report Number
    1219913-2014-00156
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Removal / Correction Number
    1219913-05/30/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE NON-REPRODUCIBLE ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULT IS UNKNOWN. THE REPEAT TESTING WAS PERFORMED ON THE SAME ADVIA CENTAUR XP. SIEMENS SENT SERVICE ON SITE. A VISUAL PROTOCOL WAS PERFORMED AND NO INSTRUMENT ISSUES WERE IDENTIFIED. A PRECISION STUDY WAS PERFORMED WITH REAGENT LOT 010084 AND THE RESULTS WERE ACCEPTABLE. A PRECISION STUDY WAS ALSO PERFORMED WITH REAGENT LOT 010086 AND CONFIRMED THAT THE SYSTEM PERFORMED ACCEPTABLY. THE SAMPLE WAS SPUN AT 3000 RPM FOR 5 -6 MINUTES. MINIMUM SPIN TIME IS USUALLY 10 MINUTES. INFORMATION REGARDING THE TYPE OF CENTRIFUGE IS NOT AVAILABLE AND IT UNKNOWN HOW LONG SAMPLES ARE ALLOWED TO CLOT BEFORE TESTING AS CENTRIFUGING OF SAMPLES IS PERFORMED OFFSITE. NO CONCLUSIONS CAN BE DRAWN. THE CUSTOMER CONFIRMED THAT THEY WERE FOLLOWING THE INSTRUCTIONS IN THE URGENT MEDICAL DEVICE CORRECTION 10818632 AT THE TIME OF THE NON-REPRODUCIBLE RESULT. THE SUMMARY AND EXPLANATION OF THE TEST SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLE 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 A NON-REPRODUCIBLE ELEVATED ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) RESULT COMPARED TO REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390859 ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. 010084

    Patients

    Seq Age Sex Outcome Treatment
    1