BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 4140751 · Received October 3, 2014

    Report

    Report Number
    1219913-2014-00244
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 16, 2014
    Report Date
    September 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE QC VARIABILITY AND THE DISCORDANT TROPONIN ULTRA RESULTS IS UNKNOWN. SIEMENS IS INVESTIGATING. 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 1219913-2014-00244 ON OCTOBER 03, 2014. 10/07/2014 ADDITIONAL INFORMATION: QUALITY CONTROL VALUES PROVIDED BY CUSTOMER FOR BIO-RAD QC LOT # 23585. THE HIGHEST VALUE WAS 0.08. (B)(6). A FIELD SERVICE ENGINEER (FSE ) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION ON 09/19/2014. THE FSE PERFORMED ANNUAL PREVENTATIVE MAINTENANCE. THE FSE REPLACED MULTIPLE PARTS INCLUDING THE REAGENT AND ASPIRATE PROBE ON THE ADVIA CENTAUR XP SN: (B)(4). NO CONCLUSION CAN BE DRAWN. THE CAUSE FOR THE QC VARIABILITY AND THE DISCORDANT TROPONIN ULTRA RESULTS IS UNKNOWN. NO FURTHER ISSUES WERE OBSERVED BY THE CUSTOMER. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED VARIABILITY FOR TROPONIN ULTRA (TNI-ULTRA) QUALITY CONTROL (QC) PRIOR TO AND WHEN USING REAGENT LOT 086. A DIFFERENT REAGENT READYPACK WITH A NEW CALIBRATION WAS USED AND THE SAME ISSUE WAS OBSERVED. THE QC WAS REPEATED WHEN THE VALUES WERE HIGH AND THE RESULTS WERE ACCEPTABLE WITHOUT ANY CHANGES MADE. THE CUSTOMER RECEIVED A NEW SHIPMENT OF TROPONIN ULTRA AND A NEW REAGENT LOT (LOT # 087). THE QC WAS RUN WITH REAGENT LOT # 087 AND THE SAME ISSUE WAS OBSERVED. A PATIENT SAMPLE WAS RUN IN REPLICATES ON REAGENT LOT # 087 AFTER THE VARIABILITY OF QC WAS OBSERVED. IMPRECISE ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) RESULTS WERE OBTAINED FOR THE PATIENT SAMPLE. THE DIFFERENCE WAS OBSERVED BETWEEN THE REPLICATES RUN. NO CORRECTED REPORTS WERE ISSUED. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619900 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010086 AND 010087

    Patients

    Seq Age Sex Outcome Treatment
    1