BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TNI-ULTRA ASSAY

    MDR report key: 7249231 · Received February 7, 2018

    Report

    Report Number
    1219913-2018-00072
    Event Type
    Malfunction
    Date Received
    February 7, 2018
    Date of Event
    January 14, 2018
    Report Date
    August 28, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    00630414516226
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR ON 02/07/2018 FOR AN ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) RESULT OBSERVED BY THE CUSTOMER WHEN PERFORMING A REAGENT LOT TO NEW REAGENT LOT CORRELATION STUDY. THE PATIENT CORRELATION SAMPLE WHEN RUN ON A PREVIOUS REAGENT LOT (010125) WAS LOWER COMPARED TO THE NEW REAGENT LOT (010127). THE TNI RESULT FROM REAGENT LOT 010125 WAS WHAT WAS INITIALLY REPORTED, AND WAS NOT QUESTIONED BY THE PHYSICIAN. 08/24/2018 - ADDITIONAL INFORMATION: MULTIPLE CUSTOMER COMPLAINTS REPORT A POSITIVE BIAS OF APPROXIMATELY 30% BETWEEN ADVIA CENTAUR TNI ULTRA REAGENT LOTS 010127 AND 010125 OR 010124 WHEN TESTING PATIENT SAMPLES AND QUALITY CONTROLS (QC) WITH CONCENTRATIONS APPROXIMATELY 0.10 NG/ML AND LOWER ON THE ADVIA CENTAUR XP/XPT. IN ADDITION, DEPRESSED QUALITY CONTROL RESULTS HAVE BEEN REPORTED ON BIO-RAD LEVEL 3 CONTROLS, WITH A NEGATIVE BIAS OF APPROXIMATELY -15%. IN SOME INSTANCES, CUSTOMER QC RESULTS FELL OUTSIDE THE CONTROL INSERT RANGES. SIMILAR REPORTS OF A LESSER MAGNITUDE HAVE ALSO BEEN REPORTED FOR TNI ULTRA REAGENT LOT 010127 ON ADVIA CENTAUR CP INSTRUMENTS. SIEMENS' COMPLAINT INVESTIGATION CONFIRMED CUSTOMER OBSERVATIONS OF BIAS WITH LOT 010127. INVESTIGATION DATA DEMONSTRATES A MEAN BIAS OF 33% BETWEEN TNI ULTRA REAGENT LOT 010127 AND 010125 FOR PATIENT SAMPLES IN THE RANGE OF 0.020 NG/ML AND 0.100 NG/ML ON THE ADVIA CENTAUR XP/XPT PLATFORM. ON THE ADVIA CENTAUR CP PLATFORM A MEAN BIAS OF 14% BETWEEN TNI ULTRA REAGENT LOT 010127 AND 010125 WAS OBSERVED FOR SAMPLES IN THE RANGE OF 0.020 NG/ML AND 0.100 NG/ML. THE ATELLICA IMMUNOASSAY ANALYZER TNI ULTRA ASSAY IS NOT IMPACTED, AS THE AFFECTED REAGENT LOT WAS NOT AVAILABLE FOR USE ON THIS PLATFORM. BIASES IN THE HIGH END OF THE ASSAY RANGE (CONCENTRATIONS APPROXIMATELY >20 NG/ML) WERE NEGATIVE, WHICH ALIGNS WITH CUSTOMER REPORTS OF A DROP IN CONTROL RECOVERY BEGINNING WITH REAGENT LOT 010127. SIEMENS TESTED QC MATERIAL AND MCMS, WHERE MEAN RESULTS MET ACCEPTABLE RANGES FOR EACH SAMPLE ON EVERY LOT AND PLATFORM BUT SHOWED SIMILAR BIASES TO PATIENT SAMPLES IN THE SAME AREA OF THE CURVE. FOR VERIFICATION PURPOSES, ADVIA CENTAUR TNI ULTRA LOTS 010125, 010128, 010130 AND 010132 WERE TESTED ON THE ADVIA CENTAUR XP AND ADVIA CENTAUR CP. PATIENT BIASES OBSERVED BETWEEN THESE LOTS WERE WITHIN EXPECTED PERFORMANCE BASED ON HISTORICAL PERFORMANCE OF THE ASSAY. ATELLICA IMMUNOASSAY ANALYZER REAGENT LOTS 010126, 010129 AND 010131 WERE ALSO TESTED AND BIASES OBSERVED BETWEEN THESE LOTS WERE SIMILAR TO OR BETTER THAN ADVIA CENTAUR SYSTEMS LOTS. IN ADDITION, A NORMAL RANGE STUDY CONFIRMED THAT ALL LOTS TESTED ARE MEETING THE REFERENCE INTERVAL AS STATED IN THE INSTRUCTIONS FOR USE AND DESIGN REQUIREMENTS (DIR). SIEMENS' INVESTIGATION CONCLUDED THAT THE BIAS OBSERVED WITH LOT 010127 IS A LOT SPECIFIC ISOLATED EVENT. SIEMENS' COMPLAINT INVESTIGATION IS COMPLETE. BASED ON THE INVESTIGATION RESULTS, SIEMENS CONCLUDES THAT ALTHOUGH ADVIA CENTAUR SYSTEMS TNI ULTRA REAGENT LOT 010127 HAS DEMONSTRATED A GREATER BIAS COMPARED TO OTHER LOTS, IT IS PERFORMING AS DESIGNED. THE INTENDED USE OF THE ASSAY IS NOT IMPACTED. SIEMENS HAS VERIFIED THAT THE PRODUCT IS MEETING ALL SPECIFICATIONS AND CLAIMS. THE AFFECTED REAGENT LOT 010127 EXPIRED ON 2018-07-08.

    Additional Manufacturer Narrative · 1

    THE FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) CORRELATION RESULT IS BEING INVESTIGATED BY SIEMENS. THE SUMMARY AND EXPLANATION OF THE TEST SECTION OF THE INSTRUCTIONS FOR USE 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." THE INTERPRETATION OR RESULTS SECTION OF THE INSTRUCTION FOR USE STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS."

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) RESULT WAS OBSERVED BY THE CUSTOMER WHEN PERFORMING A REAGENT LOT TO NEW REAGENT LOT CORRELATION STUDY. THE PATIENT CORRELATION SAMPLE WHEN RUN ON A PREVIOUS REAGENT LOT (010125) WAS LOWER COMPARED TO THE NEW REAGENT LOT (010127). THE TNI RESULT FROM REAGENT LOT 010125 WAS WHAT WAS INITIALLY REPORTED, AND WAS NOT QUESTIONED BY THE PHYSICIAN. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91265 ADVIA CENTAUR XP TNI-ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010127 00630414516226

    Patients

    Seq Age Sex Outcome Treatment
    1