BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3629354 · Received February 14, 2014

    Report

    Report Number
    1219913-2014-00033
    Event Type
    Malfunction
    Date Received
    February 14, 2014
    Date of Event
    January 22, 2014
    Report Date
    January 22, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00033 ON 02/14/2014 FOR AN ADVIA CENTAUR XP TNI ULTRA LOW QUALITY CONTROL RECOVERY WITH A NEW TROPONIN REAGENT LOT 010078. ON 04/04/2014 - ADDITIONAL INFORMATION: INITIALLY, A LOW QUALITY CONTROL LOW RECOVERY WAS OBSERVED WITH THE NEW ADVIA CENTAUR XP REAGENT LOT 010078. AFTER FURTHER INVESTIGATION, SIEMENS PROVIDED THE QUALITY CONTROL MANUFACTURER WITH UPDATED QUALITY CONTROL (QC) LOT 23550 INSERT RANGES FOR THE ADVIA CENTAUR XP FOR TROPONIN REAGENT LOT 010078. THE CUSTOMER'S QUALITY CONTROL RECOVERY IS WITHIN THE MANUFACTURES UPDATED PUBLISHED QC RANGES. BIO-RAD CARDIAC MARKERS PLUS CONTROL LT - MANUFACTURERS INSERT UPDATE: (B)(4). THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. 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 LOW ADVIA CENTAUR TROPONIN ULTRA QUALITY CONTROL RECOVERY WITH REAGENT LOT 010078 COMPARED TO THE MANUFACTURER REVISED AND PUBLISHED QUALITY CONTROL RANGES FOR THE ADVIA CENTAUR XP TROPONIN ASSAY IS UNKNOWN. THE CUSTOMER PERFORMED AN ADVIA CENTAUR TROPONIN PATIENT LOT (010077) TO NEW LOT (010078) CORRELATION STUDY AND THE PATIENT RESULTS WERE ACCEPTABLE. THE CUSTOMER HAS A SECOND ADVIA CENTAUR SYSTEM FOR TESTING TROPONIN PATIENT SAMPLES AND HAS DECLINED A SERVICE VISIT. 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 LOW TROPONIN QUALITY CONTROL RECOVERY ON THE ADVIA CENTAUR XP SYSTEM WITH A NEW REAGENT LOT (010078) WHEN COMPARED TO THE REVISED PUBLISHED MANUFACTURER QUALITY CONTROL INSERT RANGES FOR THE ADVIA CENTAUR TROPONIN ASSAY. DUE TO THE TROPONIN QUALITY CONTROL OUT LOW RECOVERY WITH THE NEW REAGENT LOT, THE CUSTOMER HAD TO RUN PATIENT TROPONIN SAMPLES ON THE SECOND ADVIA CENTAUR SYSTEM. THE TROPONIN QUALITY CONTROL RECOVERY IS RECOVERING LOWER WITH THE SECOND ADVIA CENTAUR SYSTEM, HOWEVER, THE QUALITY CONTROL RESULTS ARE WITHIN THE REVISED TROPONIN INSERT RANGES. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER TROPONIN QUALITY CONTROL MEAN RECOVERY WITH THE NEW REAGENT LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99155 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010078

    Patients

    Seq Age Sex Outcome Treatment
    1