BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TNI-ULTRA ASSAY

    MDR report key: 5442212 · Received February 17, 2016

    Report

    Report Number
    1219913-2016-00044
    Event Type
    Malfunction
    Date Received
    February 17, 2016
    Date of Event
    January 21, 2016
    Report Date
    January 21, 2016
    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
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE CSE CHECKED THE FOLLOWING: SOLID WASTE FOR DEBRIS OR FIBRIN, DISPENSE PORTS, ASPIRATE, LUMINOMETER AND DARK COUNTS. THE CAUSE FOR THE FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN. THERE WERE NO SYSTEM ERRORS OBSERVED IN THE EVENT LOG, AND SYSTEM MAINTENANCE WAS UP TO DATE. THE REAGENT WAS OBSERVED TO BE HOMOGENOUS, AND THERE WERE NO ISSUES OBSERVED BY THE CUSTOMER WITH OTHER TESTS. THE CUSTOMER PERFORMS A SAMPLE STAT SPIN OF THREE MINUTES AT 7000 RPMS PRIOR TO TESTING, THEREFORE SAMPLE COLLECTION AND HANDLING MAY BE A CONTRIBUTING FACTOR, AND PRE-ANALYTICAL VARIABLES CANNOT BE RULED OUT. NOTE: THE CUSTOMER CONTACTED SIEMENS ON (B)(6) 2016 WITH REGARDS TO ONGOING TROPONIN ISSUES, AND SIEMENS WAS NOTIFIED ON (B)(6) 2016 REGARDING THIS POTENTIAL ADVERSE PATIENT RESULT. THE INSTRUCTION FOR USE (IFU) UNDER SPECIMEN COLLECTION AND HANDLING SECTION STATES THE FOLLOWING: "THE FOLLOWING RECOMMENDATIONS FOR HANDLING AND STORING BLOOD SAMPLES ARE FURNISHED BY THE CLINICAL AND LABORATORY STANDARDS INSTITUTE (CLSI, FORMERLY NCCLS): COLLECT ALL BLOOD SAMPLES OBSERVING UNIVERSAL PRECAUTIONS FOR VENIPUNCTURE. ALLOW SAMPLES TO CLOT ADEQUATELY BEFORE CENTRIFUGATION. KEEP TUBES STOPPERED AND UPRIGHT AT ALL TIMES. DO NOT USE SAMPLES THAT HAVE BEEN STORED AT ROOM TEMPERATURE FOR LONGER THAN 4 HOURS. TIGHTLY CAP AND REFRIGERATE SPECIMENS AT 2° TO 8°C IF THE ASSAY IS NOT COMPLETED WITHIN 4 HOURS. FREEZE SAMPLES AT OR BELOW -20°C IF THE SAMPLE IS NOT ASSAYED WITHIN 24 HOURS. FREEZE SAMPLES ONLY ONCE AND MIX THOROUGHLY AFTER THAWING. FROZEN SPECIMENS CAN REMAIN FROZEN UP TO 1 MONTH IN NON-FROST FREE FREEZERS. FROZEN SAMPLES MUST BE CENTRIFUGED AT 2200 X G FOR 10 MINUTES BEFORE ANALYSIS. BEFORE PLACING SAMPLES ON THE SYSTEM, ENSURE THAT SAMPLES HAVE THE FOLLOWING CHARACTERISTICS: FREE OF FIBRIN OR OTHER PARTICULATE MATTER. FREE OF BUBBLES." THE INSTRUCTION FOR USE (IFU) 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. A POSITIVE TROPONIN RESULT IS NOT ALWAYS INDICATIVE OF MI. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSE HIGH ADVIA CENTAUR CP TROPONIN ULTRA (TNI-ULTRA) RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE ELEVATED RESULT WAS CONSIDERED DISCORDANT WHEN COMPARED TO NEGATIVE REPEAT TROPONIN TEST RESULTS. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN AND THE RESULT WAS NOT QUESTIONED. 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
    98978 ADVIA CENTAUR CP TNI-ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010104

    Patients

    Seq Age Sex Outcome Treatment
    1