BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 4149866 · Received October 7, 2014

    Report

    Report Number
    1219913-2014-00246
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 25, 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
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00246 ON 10/07/2014. THE CUSTOMER OBSERVED AN INCREASE NUMBER OF FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) RESULTS. ON 11/06/2014 - ADDITIONAL PATIENT INFORMATION: FEMALE - (B)(6). PREEXISTING MEDICAL CONDITION: RESPIRATORY DISEASE. ACTUAL TEST RESULT INFORMATION PROVIDED: REAGENT LOT: 010084, INITIAL RESULT: 0.13 UG/L, NEW REAGENT LOG: 010086, REPEAT RESULT: 0.036 UG/L. THE CUSTOMER'S IS ASSAY CALIBRATIONS AND QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF THE INCIDENT. THE CUSTOMER HAS NOT OBSERVED A SIMILAR INCREASE RATE OF FALSE POSITIVE TROPONIN ULTRA (TNI-ULTRA) RESULTS WITH A PREVIOUSLY USED REAGENT LOT (010083) AND PERFORMED TESTING WITH A NEW TROPONIN ULTRA (TNI-ULTRA) REAGENT LOT (010086). SIEMENS DISTRIBUTED UFSN (B)(4), REV B. AND URGENT MEDICAL DEVICE CORRECTION (UMDC) 10818632, REV. A FOR ADVIA CENTAUR SYSTEMS TROPONIN ULTRA READYPACK VARIABILITY INFORMING CUSTOMERS OF A POTENTIAL ISSUE FOR REAGENT LOTS ENDING IN 078,079, 082, 083 AND 084. THE NOTIFICATION INSTRUCTS CUSTOMERS TO CALIBRATE EACH READYPACK PLACED ON THE SYSTEM AND TO RUN CONTROLS TO ENSURE ACCURATE CONTROL AND PATIENT VALUES. 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

    THE CAUSE FOR THE FALSE POSITIVE TROPONIN PATIENT RESULT ON THE ADVIA CENTAUR XP SYSTEM WHEN COMPARED TO THE REPEAT NEGATIVE TROPONIN IS UNKNOWN. THE CUSTOMER'S ASSAY CALIBRATIONS AND QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AT THE TIME OF THE INCIDENT. THE CUSTOMER HAS NOT OBSERVED A SIMILAR INCREASE RATE OF FALSE POSITIVE TROPONIN RESULTS WITH A PREVIOUSLY USED REAGENT LOT (010083). NO CONCLUSION CAN BE DRAWN AS ACTUAL PATIENT RESULTS HAVE NOT BEEN PROVIDED. SIEMENS DISTRIBUTED UFSN 10818631, REV B. AND URGENT MEDICAL DEVICE CORRECTION (UMDC) 10818632, REV. A FOR ADVIA CENTAUR SYSTEMS TROPONIN ULTRA READYPACK VARIABILITY INFORMING CUSTOMERS OF A POTENTIAL ISSUE FOR REAGENT LOTS ENDING IN 078,079, 082, 083 AND 084. THE NOTIFICATION INSTRUCTS CUSTOMERS TO CALIBRATE EACH READYPACK PLACED ON THE SYSTEM AND TO RUN CONTROLS TO ENSURE ACCURATE CONTROL AND PATIENT VALUES. 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

    AN INCREASE NUMBER OF FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA (TNI-ULTRA) RESULTS HAVE BEEN OBSERVED BY THE CUSTOMER WHEN PATIENT SAMPLES WERE TESTED WITH A NEW TROPONIN REAGENT LOT. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629468 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010084

    Patients

    Seq Age Sex Outcome Treatment
    1