BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3679569 · Received March 14, 2014

    Report

    Report Number
    1219913-2014-00077
    Event Type
    Malfunction
    Date Received
    March 14, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 18, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00077 ON 03/14/2014 FOR QUALITY CONTROLS RESULTS THAT SHIFTED OUTSIDE OF THE CUSTOMER'S SPECIFICATION WITH REAGENT LOT 010079 AND THERE WAS A DELAY IN THE REPORTING OF ONE PATIENT RESULT. ON 5/23/2014 ADDITIONAL INFORMATION: THE CAUSE FOR THE SHIFT IN THE QUALITY CONTROL RESULTS OUTSIDE THE CUSTOMER'S SPECIFICATION WITH REAGENT LOT 010079 IS UNKNOWN. THE ISSUE WAS RESOLVED BY THE CUSTOMER WHEN A FRESH ADVIA CENTAUR READY PACK OF THE SAME REAGENT LOT (010079) WAS USED. THE SUSPECTED ADVIA CENTAUR READY PACK IS NOT AVAILABLE FOR FURTHER INVESTIGATION. NO CONCLUSION CAN BE DRAWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. 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."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE QUALITY CONTROLS RESULTS THAT SHIFTED OUTSIDE OF THE CUSTOMER'S SPECIFICATION WITH ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) REAGENT LOT 010079 AND THE HIGHER OBSERVED PATIENT BIAS WHEN COMPARING THE PATIENT RESULTS FROM THE TWO SITES IS UNKNOWN. A NEW READYPACK OF ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) LOT 010079 WAS PROVIDED TO THE CUSTOMER AND AFTER RE-CALIBRATION, THE QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE LIMITS. THERE HAS BEEN NO REPORT OF SERIOUS DETERIORATION OF PATIENT HEALTH OR ADVERSE PATIENT HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN TROPONIN VALUES. THE CAUSE FOR THE CONTROL AND PATIENT BIAS IS UNDER INVESTIGATION BY SIEMENS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. 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

    QUALITY CONTROLS RESULTS SHIFTED OUTSIDE OF THE CUSTOMER'S SPECIFICATION WITH ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) REAGENT LOT 010079. THE CUSTOMER RE-CALIBRATED THE TROPONIN ASSAY AND OBSERVED A HIGHER UPWARD DRIFT. A COMPARISON STUDY WAS PERFORMED ON TEN PATIENT SAMPLES WHICH WERE PREVIOUSLY TESTED AT ANOTHER SITE ON A DIFFERENT ADVIA CENTAUR SYSTEM AND TROPONIN REAGENT LOT. THERE WAS AN OBSERVED AVERAGE BIAS OF 32% WHEN COMPARING THE PATIENT RESULTS FROM THE TWO SITES. A NEW READYPACK OF ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) LOT 010079 WAS PROVIDED TO THE CUSTOMER AND AFTER RE-CALIBRATION, THE QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGE LIMITS. IN ADDITION TO THE PATIENT COMPARISON STUDY, THE CUSTOMER INFORMED SIEMENS THAT THERE WAS A DELAY IN THE REPORTING OF ONE PATIENT RESULT DUE TO THE RE-CALIBRATION AND REPEAT TESTING WITH THE NEW TROPONIN READYPACK LOT 010079. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DIFFERENCE IN TROPONIN VALUES OR THE DELAY IN REPORTING RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154728 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010079

    Patients

    Seq Age Sex Outcome Treatment
    1