BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3000408 · Received March 12, 2013

    Report

    Report Number
    1219913-2013-00039
    Event Type
    Malfunction
    Date Received
    March 12, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS TECHNICAL APPLICATION SPECIALIST (TAS) WAS SENT TO THE CUSTOMER SITE AND THE CAUSE FOR THE DISCORDANT RESULT IS BEING INVESTIGATED. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE TNI 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 MYOCARDIAL INFARCTION (MI). IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF TNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE TNI 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 TNI RESULTS IN AIDING THE DIAGNOSIS OF MI."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2013-00039 ON (B)(4) 2013. (B)(4) 2013 - ADDITIONAL INFORMATION A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND PERFORMED A TOTAL SERVICE CALL. THE FSE REPLACED THE ACID DELIVERY LINE, A LEAKY BASE PUMP AND REAGENT PROBE. THE CUSTOMER HAS NOT REPORTED ANY FURTHER ISSUES WITH DISCORDANT TROPONIN RESULTS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO A NEGATIVE TEST RESULT WHEN RUN ON ANOTHER ADVIA CENTAUR CP SYSTEM. THE CUSTOMER PERFORMED REPEAT TESTING DUE TO THE INITIALLY POSITIVE RESULT. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104057 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1