BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3651729 · Received February 27, 2014

    Report

    Report Number
    1219913-2014-00051
    Event Type
    Malfunction
    Date Received
    February 27, 2014
    Date of Event
    January 30, 2014
    Report Date
    February 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE CUSTOMER'S OBSERVED HIGHER TROPONIN QUALITY CONTROL MEAN RECOVERY ON THE ADVIA CENTAUR XP SYSTEM WITH TWO NEW REAGENT LOTS (010079) AND REAGENT LOT (010082) WHEN COMPARED TO THE QUALITY CONTROL MEAN RECOVERY RESULTS FROM A PREVIOUS RUN TROPONIN REAGENT LOT (010078) AND ESTABLISHED TROPONIN QUALITY CONTROL LIMITS AT THE TIME IS UNKNOWN. THE CUSTOMER WAS PROVIDED WITH THE MANUFACTURER'S REVISED AND PUBLISHED TROPONIN QUALITY CONTROL LIMITS FOR THE ADVIA CENTAUR XP TROPONIN ASSAY AND THE RESULTS ARE WITHIN ACCEPTABLE LIMITS WHEN RUN WITH TROPONIN REAGENT LOT (010079) AND LOT (010082). SIEMENS IS INVESTIGATING FURTHER. NO CONCLUSION CAN BE DRAWN. THE INSTRUCTION FOR USE UNDER THE QUALITY CONTROL SECTION STATES THE FOLLOWING: "SIEMENS HEALTHCARE DIAGNOSTICS RECOMMENDS THE USE OF COMMERCIALLY AVAILABLE QUALITY CONTROL MATERIALS WITH AT LEAST 2 LEVELS (LOW AND HIGH). A SATISFACTORY LEVEL OF PERFORMANCE IS ACHIEVED WHEN THE ANALYTE VALUES OBTAINED ARE WITHIN THE ACCEPTABLE CONTROL RANGE FOR THE SYSTEM OR WITHIN YOUR RANGE, AS DETERMINED BY AN APPROPRIATE INTERNAL LABORATORY QUALITY CONTROL SCHEME. IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS. TAKE THE FOLLOWING ACTIONS: VERIFY THAT THE MATERIALS ARE NOT EXPIRED. VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED. VERIFY THAT THE ASSAY WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. RERUN THE ASSAY WITH FRESH QUALITY CONTROL SAMPLES. IF NECESSARY, CONTACT YOUR LOCAL TECHNICAL SUPPORT PROVIDER OR DISTRIBUTOR FOR ASSISTANCE." 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

    THE CUSTOMER OBSERVED HIGHER TROPONIN QUALITY CONTROL MEAN RECOVERY ON THE ADVIA CENTAUR XP SYSTEM WITH TWO NEW REAGENT LOTS (010079) AND REAGENT LOT (010082). THE MEAN QUALITY CONTROL RESULTS WERE CONSIDERED HIGHER WHEN COMPARED TO THE QUALITY CONTROL MEAN RECOVERY RESULTS FROM A PREVIOUS RUN TROPONIN REAGENT LOT (010078) AND ESTABLISHED TROPONIN QUALITY CONTROL LIMITS AT THE TIME. THE MANUFACTURER HAS UPDATED AND PUBLISHED REVISED TROPONIN QUALITY CONTROL LIMITS FOR THE ADVIA CENTAUR XP TROPONIN ASSAY. IT WAS OBSERVED BY THE CUSTOMER THAT WITH THE MANUFACTURER'S UPDATED AND REVISED PUBLISHED QUALITY CONTROL RANGES FOR (QC LOT 23540), THEIR QUALITY CONTROL MEAN RECOVERY FOR LEVEL 3 WAS OUT OF RANGE LOW WITH TROPONIN REAGENT LOT 010078. THE CUSTOMER'S QUALITY CONTROL RESULTS HOWEVER WITH THE MANUFACTURER'S REVISED AND PUBLISHED TROPONIN QUALITY CONTROL LIMITS FOR THE ADVIA CENTAUR XP TROPONIN ASSAY WAS WITHIN ACCEPTABLE RANGE LIMITS WITH TROPONIN REAGENT LOT (010079) AND LOT (010082). THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGHER TROPONIN QUALITY CONTROL MEAN RECOVERY WITH THE TWO NEW TROPONIN REAGENT LOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122535 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010079, 010082

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown