BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) ASSAY

    MDR report key: 4199824 · Received October 24, 2014

    Report

    Report Number
    1219913-2014-00265
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 13, 2014
    Report Date
    October 17, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT TROPONIN ULTRA RESULTS IS UNKNOWN. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. INSPECTION IN PROCESS. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00265 ON OCTOBER 24, 2014. ON 01/06/2015 ADDITIONAL INFORMATION: A CUSTOMER SERVICE ENGINEER (CSE ) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE CSE REPLACED THE VALVE MANIFOLD IN DISPENSE PORT 3 ON THE ADVIA CENTAUR SN: (B)(4). THE IMPRECISION WITH REAGENT LOT 010086 WAS RESOLVED. THE CUSTOMER WAS PROVIDED WITH TROPONIN ULTRA REAGENT LOT # 010087 FOR TROUBLESHOOTING. THERE WERE NO PRECISION ISSUES OBSERVED WITH REAGENT LOT 010087. THE REAGENT LOT 010087 MET THE CUSTOMER'S EXPECTATIONS. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    IMPRECISE ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED ON TWENTY FIVE PATIENT SAMPLES DURING A METHOD EVALUATION OF REAGENT LOT # 010086. NO RESULTS WERE REPORTED TO PHYSICIANS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679144 ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010086

    Patients

    Seq Age Sex Outcome Treatment
    1