BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA)

    MDR report key: 3611102 · Received February 6, 2014

    Report

    Report Number
    1219913-2014-00021
    Event Type
    Malfunction
    Date Received
    February 6, 2014
    Date of Event
    January 14, 2014
    Report Date
    January 14, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K53020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00021 ON FEBRUARY 06, 2014.ON 05/13/2014 ADDITIONAL INFORMATION:SIEMENS INVESTIGATED INTERNALLY. FURTHER INTERNAL INVESTIGATION SHOWED THAT THE REAGENT LOTS ARE MEETING SPECIFICATIONS AND ARE CONSISTENT WITH IFU RESULTS.NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED THE HIGH QUALITY CONTROL BIAS WITH ADVIA CENTAUR CP TROPONIN ULTRA LOT 010079 WHILE PERFORMING A COMPARISON TO ADVIA CENTAUR CP TROPONIN ULTRA LOT 010078. NO PATIENT RESULTS WERE REPORTED WITH LOT 010079 SINCE THE CUSTOMER WAS EVALUATING THE LOT. THE CUSTOMER CONTINUED TO REPORT RESULTS WITH REAGENT LOT 010078. SERVICE WAS NOT SENT ON SITE SINCE ADVIA CENTAUR CP TROPONIN ULTRA LOT 010078 YIELDED QUALITY CONTROL RESULTS WITHIN THE CUSTOMER'S DEFINED RANGES AND BOTH LOTS OF REAGENTS YIELDED RESULTS WITHIN THE MANUFACTURER'S PUBLISHED RANGES. SIEMENS CONTINUES TO TROUBLESHOOT THE QUALITY CONTROL BIAS. THE QUALITY CONTROL SECTION OF THE INSTRUCTIONS FOR USE (IFU) 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 SUMMARY AND EXPLANATION OF THE TEST SECTION OF THE IFU 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

    DURING EVALUATION OF ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA) REAGENT LOT 010079, THE CUSTOMER NOTED THAT THE QUALITY CONTROL RESULTS SHOWED A HIGH BIAS COMPARED TO REAGENT LOT 010078 AND THE RESULTS WERE OUTSIDE THE CUSTOMER'S ESTABLISHED RANGES. THE CUSTOMER REPORTED THAT A PATIENT METHOD COMPARISON BETWEEN REAGENT LOTS 010078 AND 010079 WAS PERFORMED AND THE RESULTS WERE WITHIN THE CUSTOMER'S ACCEPTABLE LIMITS OF 0.02 NG/ML AND/OR 20% DIFFERENCE BETWEEN REAGENT LOTS. THERE ARE NO REPORTS OF PRESCRIBED OR ALTERED TREATMENT OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH ADVIA CENTAUR CP TNI ULTRA QUALITY CONTROL BIAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76707 ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA) TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010079

    Patients

    Seq Age Sex Outcome Treatment
    1