BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3751981 · Received April 15, 2014

    Report

    Report Number
    1219913-2014-00094
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) AND FIELD APPLICATION SPECIALIST (FAS) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION AND FOUND NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE FALSE POSITIVE TROPONIN PATIENT RESULTS. THE CAUSE FOR THE FALSE POSITIVE ADVIA CENTAUR CP PATIENT RESULTS IS UNKNOWN. NO CONCLUSION CAN BE DRAWN. THE FIELD APPLICATION SPECIALIST DID OBSERVE WHILE ON SITE THAT THE CUSTOMER'S LIQUID CARDIAC MARKER PLUS LT CONTROL LEVEL 1, LOT 23551 RESULTS WERE CONSISTENTLY AT THE UPPER LIMIT OF THE QUALITY CONTROL RANGE. THE CUSTOMER WAS MADE AWARE THAT THE QUALITY CONTROL MANUFACTURER HAD PUBLISHED AN UPDATE TO THE QUALITY CONTROL INSERT VALUE FOR QUALITY CONTROL LOT (23550) AND ADVIA CENTAUR REAGENT LOT 010079. THE CUSTOMER'S QUALITY CONTROL MEAN RECOVERY IS CLOSER TO THE MANUFACTURER UPDATED MEAN INSERT VALUE. BIO-RAD LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT - UPDATED INSERT VALUE.LOT 23550: MEAN (UG/L): RANGE (UG/L): LEVEL 1 (LOT 23551); 0.086; 0.052 - 0.121. CUSTOMER'S OBSERVED LEVEL 1 (LOT 23551) QUALITY CONTROL MEAN RECOVERY: 0.08 UG/L.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." THE INSTRUCTION FOR USE (IFU) UNDER THE QUALITY CONTROL SECTION STATES THE FOLLOWING: "IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS WERE OBTAINED BY THE CUSTOMER ON TWO PATIENT SAMPLES. FOR THE FIRST PATIENT, A SECOND AND THIRD SAMPLE WAS DRAWN AND THE RESULTS WERE NEGATIVE. THE CUSTOMER PERFORMED REPEAT TESTING ON THE INITIAL (FIRST) SAMPLE AND THE RESULT WAS NEGATIVE. FOR THE SECOND PATIENT, THE TEST SAMPLE WAS RUN IN DUPLICATE. THE TROPONIN RESULT FOR THE FIRST DUPLICATE WAS NEGATIVE AND POSITIVE FOR SECOND DUPLICATE RESULT. THE PATIENT SAMPLE WAS REPEATED AND THE RESULTS WERE NEGATIVE. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229342 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010079

    Patients

    Seq Age Sex Outcome Treatment
    1