BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3012349 · Received March 20, 2013

    Report

    Report Number
    1219913-2013-00063
    Event Type
    Malfunction
    Date Received
    March 20, 2013
    Date of Event
    February 19, 2013
    Report Date
    February 22, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TROPONIN ULTRA RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. 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." 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."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR XP TROPONIN ULTRA RESULT WAS OBTAINED BY THE CUSTOMER AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AS THE PATIENT DID NOT HAVE ANY CARDIAC SYMPTOMS. REPEAT TESTING WAS PERFORMED ON A DIFFERENT SAMPLE TUBE AND THE RESULT WAS NEGATIVE. THE CUSTOMER PULLED THE SAMPLE IN QUESTION FROM THE REFRIGERATOR AND FOUND THAT THE SERUM WAS CLOTTED. THE CUSTOMER REPEATED THE SAMPLES BEFORE AND AFTER THIS SAMPLE AND BOTH RESULTS WERE NEGATIVE. 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
    115251 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 070

    Patients

    Seq Age Sex Outcome Treatment
    1