BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3870098 · Received June 12, 2014

    Report

    Report Number
    1219913-2014-00135
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 18, 2014
    Report Date
    May 19, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE FALSELY ELEVATED ADVIA CENTAUR CP TNI ULTRA RESULT IS UNKNOWN. A SIEMENS FIELD SERVICE ENGINEER (FSE) WENT ON SITE AND VERIFIED THE CALIBRATION OF THE PROBES AND OTHER SETTINGS AND CALIBRATION. PREVENTATIVE MAINTENANCE WAS PERFORMED ON THE INSTRUMENT. THE ASPIRATE WASH STATIONS WERE REPLACED. OPERATION WAS VERIFIED AND THE SYSTEM WAS FULLY FUNCTIONAL UPON THE FSE'S DEPARTURE FROM THE SITE. NO CONCLUSIONS CAN BE DRAWN. THE CUSTOMER'S QUALITY CONTROL RESULTS WERE WITHIN ACCEPTABLE RANGES AND THERE WERE NO OTHER DISCORDANT PATIENT RESULTS REPORTED AT THE TIME OF THE ISSUE. NO CONCLUSION CAN BE DRAWN. 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 SPECIMEN COLLECTION AND HANDLING SECTION STATES THE FOLLOWING: "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: SAMPLES ARE FREE OF FIBRIN OR OTHER PARTICULATE MATTER. SAMPLES ARE FREE OF BUBBLES." THE SYSTEM IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A FALSELY ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA) RESULT WAS OBTAINED BY A CUSTOMER ON A PATIENT SAMPLE. THE PHYSICIAN QUESTIONED THE RESULTS AND A NEW SAMPLE WAS DRAWN AND THE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE WITHIN NORMAL LIMITS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE RESULT. THERE IS NO KNOWN REPORTS 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
    348628 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010083

    Patients

    Seq Age Sex Outcome Treatment
    1