BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 4181815 · Received October 17, 2014

    Report

    Report Number
    1219913-2014-00254
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 21, 2014
    Report Date
    September 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00254 ON 10/17/2014 FOR FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULTS ON TWO PATIENT SAMPLES. 01/14/2014 ADDITIONAL INFORMATION: A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE DID NOT OBSERVE ANY INSTRUMENT ISSUES THAT MAY HAVE CONTRIBUTED TO THE INITIALLY DISCORDANT PATIENT RESULTS. THE CAUSE FOR THE INITIALLY POSITIVE TROPONIN RESULTS, COMPARED TO THE LOWER RESULTS WHEN THE SAME SAMPLES WERE REPEATED IS UNKNOWN. THERE WERE NO OTHER DISCORDANT TROPONIN RESULTS OBSERVED FROM THIS SYSTEM AFTER THE CSE INSPECTION. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY POSITIVE TROPONIN RESULTS, COMPARED TO THE NEGATIVE RESULTS WHEN THE SAME SAMPLES WERE REPEATED IS UNKNOWN. SIEMENS IS INVESTIGATING FURTHER. NO CONCLUSION CAN BE DRAWN. 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

    FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR TWO PATIENT SAMPLES. THE POSITIVE TROPONIN RESULTS WERE CONSIDERED DISCORDANT WHEN THE SAME SAMPLES WERE REPEATED AND THE RESULTS NEGATIVE. FOR INITIALLY ELEVATED TROPONIN TEST RESULTS, THE CUSTOMER PERFORMS DUPLICATE REPEAT TESTING. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE IS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR CP TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662237 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010087

    Patients

    Seq Age Sex Outcome Treatment
    1