BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 2914033 · Received January 14, 2013

    Report

    Report Number
    1219913-2013-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 14, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2013 - CORRECTED INFORMATION: INITIAL TROPONIN RESULT WAS 2.098 NG/ML ON (B)(6) 2013 - ADDITIONAL INFORMATION A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND PERFORMED A TOTAL SERVICE CALL. THE FSE REPLACED THE WASTE RESERVOIR CAP DUE TO A VACUUM LEAK AND REPLACED THE ASPIRATE # 4 TUBING DUE TO AN OBSERVED HOLE IN THE TUBING. ALL OTHER TOTAL SERVICE SYSTEM CHECKS WERE FOUND TO BE ACCEPTABLE. INSTRUMENT SUPPORT HAS REVIEWED THE FSE SERVICE REPORT AND IT IS UNLIKELY THAT THE WORK PERFORMED WAS A CONTRIBUTING FACTOR AS THERE WERE NO OTHER KNOWN DISCORDANT TROPONIN RESULTS REPORTED AT THE TIME OF THE EVENT. THE CAUSE FOR THE FALSE POSITIVE RESULT MAY BE ATTRIBUTED TO SPECIMEN COLLECTION AND HANDLING. THE INSTRUCTION FOR USE (IFU) STATES THE FOLLOWING IN THE SPECIMEN COLLECTION AND HANDLING: "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."

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE INITIALLY POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULT WHEN COMPARED TO THE REPEAT NEGATIVE TEST RESULTS IS UNKNOWN. THE INSTRUCTION FOR USE UNDER THE SUMMARY AND EXPLANATION OF THE TEST SECTION STATES THE FOLLOWING: "ALWAYS ANALYZE TNI 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 MYOCARDIAL INFARCTION (MI). IN ACCORD WITH PUBLISHED RECOMMENDATIONS, SERIAL TESTING OF TNI AT INTERVALS OF 2 TO 4 HOURS FOR UP TO 12 TO 24 HOURS IS SUGGESTED TO CORROBORATE A SINGLE TNI 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 TNI RESULTS IN AIDING THE DIAGNOSIS OF MI." NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO A REPEAT NEGATIVE TEST RESULT. THE PATIENT SAMPLE WAS ALSO REPEATED ON ANOTHER ADVIA CENTAUR SYSTEM AND THE RESULT WAS NEGATIVE. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TROPONIN ULTRA RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21348 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 069

    Patients

    Seq Age Sex Outcome Treatment
    1