BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 2854283 · Received December 3, 2012

    Report

    Report Number
    1219913-2012-00402
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    November 6, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) 2012: ADDITIONAL INFORMATION: SIEMENS HEALTHCARE DIAGNOSTICS RECEIVED UPDATED PATIENT RESULTS. (B)(6). CORRECTED DATA: INCORRECT CATALOG NUMBER REPORTED: 10317709, CORRECT CATALOG NUMBER: 02789602.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE CLEANED THE LUMINOMETER AND DEIONISATOR. THE REAGENT PROBE TUBE SYSTEM WAS CLEANED WITH HYPOCHLORIDE. THE FSE CHANGED THE TUBING ON THE WASTE PERISTALTIC PUMP. QUALITY CONTROLS ARE WITHIN RANGE. THE PART REPLACED BY THE FSE WAS NOT CONSIDERED A CONTRIBUTING CAUSE FOR THE DISCORDANT RESULT. NO CONCLUSION CAN BE DRAWN. 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."

    Description of Event or Problem · 1

    A FALSE POSITIVE ADVIA CENTAUR CP TROPONIN ULTRA PATIENT SAMPLE TEST RESULT WAS OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED TO REPEAT SAMPLE TESTING AND REDRAW SAMPLE TESTING. BASED ON THE INITIAL POSITIVE RESULT, THE PHYSICIAN PERFORMED A CARDIAC CATHETERIZATION WHICH WAS INCONSPICUOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 94613066

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other