BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY

    MDR report key: 6066956 · Received October 31, 2016

    Report

    Report Number
    1219913-2016-00199
    Event Type
    Malfunction
    Date Received
    October 31, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 31, 2016
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER OBSERVED A FIBRIN CLOT IN THE SAMPLE. PREANALYTIC VARIABLES CAN AFFECT THE QUALITY OF THE SAMPLE, AND DEVIATION FROM RECOMMENDED BEST PRACTICES CAN LEAD TO ERRONEOUS RESULTS. WHILE THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE CAUSE OF THE FALSE RESULTS, PREANALYTIC FACTORS LEADING TO FIBRIN INTERFERENCE AS THE CAUSATIVE AGENT CANNOT BE RULED OUT. THE INSTRUCTION FOR USE (IFU) FOR ADVIA CENTAUR XP TROPONIN ULTRA 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. A POSITIVE TROPONIN RESULT IS NOT ALWAYS INDICATIVE OF MI. THESE CONDITIONS INCLUDE, BUT ARE NOT LIMITED TO, MYOCARDITIS, CARDIAC SURGERY, ANGINA, UNSTABLE ANGINA, CONGESTIVE HEART FAILURE, AND NON-CARDIAC RELATED CAUSES, SUCH AS, RENAL FAILURE AND PULMONARY EMBOLISM." THE INSTRUCTION FOR USE (IFU) FOR ADVIA CENTAUR XP CKMB UNDER THE INTERPRETATION OF RESULTS SECTION STATES THE FOLLOWING: "SERIAL SAMPLING AT THE APPROPRIATE TIME INTERVALS WILL RESULT IN THE TYPICAL RISE AND FALL PATTERN OF CK-MB LEVELS IN PATIENTS EXPERIENCING MYOCARDIAL INFARCTION. ELEVATED CK-MB LEVELS MAY BE RELATED TO NON-AMI EVENTS SUCH AS CONGESTIVE HEART FAILURE, STRENUOUS EXERCISE, OR TRAUMA. THESE EVENTS SHOULD BE CONSIDERED WHEN INTERPRETING CK-MB RESULTS." BRAND NAME: ADVIA CENTAUR XP CK-MB, COMMON DEVICE NAME: CK-MB IMMUNOASSAY, PRODUCT CODE: JHS, CATALOG# 10309982, LOT# 205, EXPIRATION DATE: 06/03/2017, UDI (B)(4). PMA/510K: K962126.

    Description of Event or Problem · 1

    CUSTOMER OBSERVED ELEVATED RESULTS FOR ADVIA CENTAUR XP TROPONIN-ULTRA (TNI-ULTRA) AND CK-MB WHICH DID NOT REPRODUCE WITH REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA AND CK-MB RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719509 ADVIA CENTAUR XP TROPONIN ULTRA (TNI-ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 04614110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR