BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3626124 · Received February 13, 2014

    Report

    Report Number
    1219913-2014-00032
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 21, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00032 ON 02/13/2014 FOR AN ADVIA CENTAUR XP TNI ULTRA HIGH QUALITY CONTROL RECOVERY WITH TROPONIN REAGENT LOT 010079 COMPARED TO THE QUALITY CONTROL MEAN RECOVERY OF TROPONIN REAGENT LOTS 010075, LOT 010077 AND LOT 010078. ON 04/04/2014 - ADDITIONAL INFORMATION: SIEMENS PROVIDED THE QUALITY CONTROL MANUFACTURER WITH UPDATED QUALITY CONTROL (QC) LOT 23570 INSERT RANGES ON THE ADVIA CENTAUR SYSTEM FOR TROPONIN REAGENT LOT 010078 AND REAGENT LOT 010079. THE CUSTOMER'S QUALITY CONTROL DATA IS CONSISTENT WITH THE QUALITY CONTROL INSERT RANGES FOR QC LOT 23570 AND THE ADVIA CENTAUR XP REAGENT LOTS. BIO-RAD CARDIAC MARKERS PLUS CONTROL LT - MANUFACTURERS INSERT UPDATE: (B)(4). THE INSTRUCTION FOR USE UNDER THE QUALITY CONTROL SECTION STATES THE FOLLOWING: "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 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

    THE CAUSE FOR THE HIGHER ADVIA CENTAUR TROPONIN ULTRA QUALITY CONTROL MEAN RECOVERY FOR REAGENT LOT 010079 COMPARED TO PREVIOUS TROPONIN REAGENT LOTS IS UNKNOWN. THE CUSTOMER HAS OBSERVED VALID TROPONIN ASSAY CALIBRATIONS AND THE ADVIA CENTAUR XP REAGENT LOT (010079) QUALITY CONTROL RECOVERY ALTHOUGH HIGHER IS WITHIN THE MANUFACTURER REVISED AND PUBLISHED QUALITY CONTROL RANGES FOR THE ADVIA CENTAUR XP TROPONIN ASSAY. THE CUSTOMER IS ALSO UTILIZING LABORATORY DEFINED TROPONIN QUALITY CONTROL RANGES AND PATIENT RESULTS HAVE NOT BEEN AFFECTED. NO CONCLUSION CAN BE DRAWN AND SIEMENS IS INVESTIGATING FURTHER. 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

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00032 ON 02/13/2014 FOR AN ADVIA CENTAUR XP TNI ULTRA HIGH QUALITY CONTROL RECOVERY WITH TROPONIN REAGENT LOT 010079 COMPARED TO THE QUALITY CONTROL MEAN RECOVERY OF TROPONIN REAGENT LOTS 010075, LOT 010077 AND LOT 010078. MDR 1219913-2014-00032 SUPPLEMENTAL REPORT 1 WAS FILED ON 04/04/2014 FOR ADDITIONAL QC INFORMATION. 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

    THE CUSTOMER OBSERVED A HIGHER TROPONIN QUALITY CONTROL MEAN RECOVERY ON THE ADVIA CENTAUR XP SYSTEM (SN (B)(4)) WITH A NEW TROPONIN REAGENT LOT (010079). THE QUALITY CONTROL RESULTS WERE CONSIDERED HIGHER WHEN COMPARED TO THE QUALITY CONTROL MEAN RECOVERY RESULTS OF PREVIOUS RUN TROPONIN REAGENT LOTS AND TWO OTHER ADVIA CENTAUR XP SYSTEMS WITHIN THE LABORATORY. DUE TO THE HIGHER TROPONIN QUALITY CONTROL MEAN RECOVERY WITH THE NEW REAGENT LOT OBSERVED ON THE ADVIA CENTAUR XP SYSTEM (SN (B)(4)), THERE WAS A FEW HOURS DELAY IN THE REPORTING OF PATIENT RESULTS UNTIL A PATIENT TROPONIN REAGENT LOT TO REAGENT LOT STUDY WAS COMPLETED AND IT WAS DETERMINED THAT PATIENT RESULTS WERE ACCEPTABLE. 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 NEW REAGENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95696 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