BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3956195 · Received July 24, 2014

    Report

    Report Number
    1219913-2014-00180
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 16, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Removal / Correction Number
    1219913-05/30/2014-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND PERFORMED A TOTAL SERVICE CALL. THE CUSTOMER INFORMED THE CSE OF ERRATIC QUALITY CONTROL (QC) RESULTS PRIOR TO THE WEEKLY CLEANING THAT MORNING. THERE WERE NO OBSERVED ISSUES WITH TUBING'S OR PUMPS. THE ASPIRATION AND DISPENSE TESTS FOR THE WASH STATION AND LUMINOMETER WERE WITHIN SPECIFICATIONS AND THE LUMINOMETER WAS CLEANED. THE SAMPLE AND REAGENT PROBE TUBING'S WERE CHECKED AND THE PROBE HEADS CLEANED. A SMALL WATER DROPLET WAS OBSERVED NEAR DP2 WHEN THE RINSE WASH BLOCK TEST WAS PERFORMED, HOWEVER, FULL ASPIRATION WAS OBSERVED AT THE END OF THE CYCLE. THE RINSE WASH BLOCK 1 WAS REPLACED. THE CAUSE FOR THE DISCORDANT POSITIVE PATIENT RESULT IS UNKNOWN. THE CUSTOMER HAS BEEN CALIBRATING AND PERFORMING QUALITY CONTROL ON EACH NEW ADVA CENTAUR CP READY PACK PRIOR TO USE, HOWEVER WHEN QC RESULTS ARE NOT WITHIN ACCEPTABLE RANGES LIMITS, THE QC IS REPEATED UNTIL THE QC RESULTS ARE ACCEPTABLE. DATE: (B)(6) 2014 . TIME: 08:21. CUSTOMER'S QC: RESULTS: TV: SD: LEVEL 1 (23574), 0.125 NG/ML, 0.130, 0.01. LEVEL 2 (23575), 2.21 NG/ML, 2.15, 0.15. LEVEL 3 (23576), 12.44 NG/ML, 12.45, 1.0. DATE: (B)(6) 2014. TIME: 14:02. CUSTOMER'S QC: RESULTS: LEVEL 1 (23574), 0.136 NG/ML. LEVEL 2 (23575), 2.17 NG/ML. LEVEL 3 (23576), 13.9 NG/ML - HIGH. DATE: (B)(6) 2014. TIME: RESULTS: QC LEVEL 3 REPEATED, 14:31, 14.1 NG/ML - HIGH. QC LEVEL 3 REPEATED, 14:55, 13.19 NG/ML - IN RANGE. SIEMENS HAS RELEASED UFSN 10818631, REV. A MAY 2014 AND UMDC 10818632, REV. A MAY 2014 FOR TROPONIN ULTRA READYPACK VARIABILITY INFORMING CUSTOMERS OF THE ISSUE FOR LOT #S 078, 079, 082, 083, AND 084. THE NOTIFICATIONS INSTRUCT CUSTOMERS TO CALIBRATE EACH READYPACK PLACED ON THE SYSTEM AND TO RUN CONTROLS TO ENSURE ACCURATE CONTROL AND PATIENT VALUES. 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." THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT WAS OBTAINED ON AN EMERGENCY DEPARTMENT PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE POSITIVE TROPONIN RESULT WAS CONSIDERED DISCORDANT COMPARED TO A NEGATIVE TROPONIN RESULT TESTED AT AN ALTERNATE LABORATORY SITE ON ANOTHER ADVIA CENTAUR CP SYSTEM. THE CUSTOMER HAD SENT THE PATIENT TEST SAMPLE TO AN ALTERNATE LABORATORY SITE FOR TESTING AS PART OF A MONTHLY ADVIA CENTAUR CP SYSTEM CORRELATION STUDY. THE ALTERNATE LABORATORY TEST RESULT FOR TROPONIN WAS NEGATIVE. THE PATIENT WAS DRAWN A SECOND TIME APPROXIMATELY THREE HOURS LATER AND THE TROPONIN TEST RESULT WAS NEGATIVE. AN AMENDED TEST REPORT WAS PROVIDED TO THE PHYSICIAN. THERE IS NO KNOWN REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433983 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010082

    Patients

    Seq Age Sex Outcome Treatment
    1