BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3720881 · Received April 2, 2014

    Report

    Report Number
    1219913-2014-00078
    Event Type
    Malfunction
    Date Received
    April 2, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 8, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WENT ON SITE AND PERFORMED A TOTAL SERVICE CALL. THE WASH BLOCK WAS REPLACED AND THE MECHANICAL ALIGNMENT OF THE REAGENT PROBE AND SAMPLE PROBE WERE CHECKED. THE ACID AND BASE LINES WERE DECONTAMINATED AND THE DISPENSE VOLUME OF THE ACID AND BASE WERE CHECKED. WATER AND WASH 1 WERE REPLACED ON THE SYSTEM. THE SYSTEM WAS PRIMED. PRECISION OF THE ASSAY WAS CONFIRMED AND MASTER CURVE MATERIAL WERE TESTED AND WERE IN RANGE. THE SYSTEM WAS OPERATIONAL UPON DEPARTURE. THE CUSTOMER CONTINUED TO OBSERVE QUALITY CONTROL RESULTS WHICH WERE HIGH OUT OF THEIR DEFINED RANGE WHEN USING ADVIA CENTAUR TNI ULTRA REAGENT LOT 010082. QUALITY CONTROL RESULTS WERE WITHIN THEIR DEFINED RANGE WHEN THE CUSTOMER RAN QUALITY CONTROL MATERIAL WITH ADVIA CENTAUR TNI ULTRA REAGENT LOT 010078. THE CUSTOMER PERFORMED A PATIENT CORRELATION BETWEEN ADVIA CENTAUR CP TNI ULTRA REAGENT LOTS 010078 AND 010082 AND FOUND THE CORRELATION ACCEPTABLE. (NO DATA PROVIDED.) THE CUSTOMER RAN THE MASTER CURVE MATERIAL USING ADVIA CENTAUR CP TNI ULTRA LOT 010082 ON MARCH 9, 2014 AND REPORTED THE RESULTS WERE ACCEPTABLE. (NO DATA PROVIDED.) THE CUSTOMER RAN QUALITY CONTROL MATERIAL ON (B)(4) 2014 WITH ADVIA CENTAUR CP TNI ULTRA LOT 010082 AND THE RESULTS WERE OUTSIDE THE CUSTOMER RANGES BUT WITHIN THE MANUFACTURER'S RANGES FOR USE WITH ADVIA CENTAUR CP TNI ULTRA LOT 010079 AND ABOVE. THE CUSTOMER CURRENTLY TESTS PATIENT SAMPLES WITH ADVIA CENTAUR CP REAGENT LOT 010078 AND OBSERVES QUALITY CONTROL RESULTS WITHIN THEIR DEFINED RANGES. BASED ON THE PATIENT CORRELATION RESULTS AND THE MASTER CURVE MATERIAL RESULTS, THE CUSTOMER WILL MOVE TO ADVIA CENTAUR XP TNI ULTRA LOT 010082 UPON DEPLETION OF LOT 010078. NO FURTHER INVESTIGATION IS REQUIRED. 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."

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00078 ON APRIL 02, 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED QUALITY CONTROL VALUES WHICH WERE HIGH OUTSIDE OF THEIR DEFINED 2SD RANGES FOR ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA). THERE ARE NO REPORTS OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE HIGH QUALITY CONTROL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198631 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010082

    Patients

    Seq Age Sex Outcome Treatment
    1