BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA ASSAY

    MDR report key: 3583761 · Received January 21, 2014

    Report

    Report Number
    1219913-2014-00010
    Event Type
    Malfunction
    Date Received
    January 21, 2014
    Date of Event
    December 26, 2013
    Report Date
    December 26, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE COMPLETED A TOTAL SERVICE CALL AND REPLACED THE 250 MICROLITER SYRINGE, 2 ML DILUTOR PLUNGER, DILUTOR PROBE 1, PROBE 3 AND FLUSHED THE SYSTEM. THE CUSTOMER HAS OBSERVED LOW QUALITY CONTROL RECOVERY RESULTS POST THE FSE VISIT. THE CAUSE FOR THE LOW ADVIA CENTAUR TROPONIN ULTRA QUALITY CONTROL RECOVERY IS UNKNOWN AND UNDER INVESTIGATION. THERE WAS AN INITIAL DELAY IN THE REPORTING OF TROPONIN PATIENT RESULTS ON THE ADVIA CENTAUR SYSTEM; HOWEVER THE CUSTOMER PERFORMED REPEAT TROPONIN TESTING ON AN ALTERNATE TROPONIN TEST METHOD AND SYSTEM. THE CUSTOMER HAS BEEN PROVIDED WITH A NEW ADVIA CENTAUR TROPONIN REAGENT LOT (010079) AND QUALITY CONTROL RECOVERY IS WITHIN THE REVISED AND PUBLISHED MANUFACTURER'S QUALITY CONTROL RANGES FOR THE ADVIA CENTAUR TROPONIN ASSAY. THE INSTRUCTION FOR USE UNDER THE QUALITY CONTROL SECTION STATES THE FOLLOWING: "SIEMENS HEALTHCARE DIAGNOSTICS RECOMMENDS THE USE OF COMMERCIALLY AVAILABLE QUALITY CONTROL MATERIALS WITH AT LEAST 2 LEVELS (LOW AND HIGH). A SATISFACTORY LEVEL OF PERFORMANCE IS ACHIEVED WHEN THE ANALYTE VALUES OBTAINED ARE WITHIN THE ACCEPTABLE CONTROL RANGE FOR THE SYSTEM OR WITHIN YOUR RANGE, AS DETERMINED BY AN APPROPRIATE INTERNAL LABORATORY QUALITY CONTROL SCHEME. IF THE QUALITY CONTROL RESULTS DO NOT FALL WITHIN THE EXPECTED VALUES OR WITHIN THE LABORATORY'S ESTABLISHED VALUES, DO NOT REPORT RESULTS. TAKE THE FOLLOWING ACTIONS: VERIFY THAT THE MATERIALS ARE NOT EXPIRED. VERIFY THAT REQUIRED MAINTENANCE WAS PERFORMED. VERIFY THAT THE ASSAY WAS PERFORMED ACCORDING TO THE INSTRUCTIONS FOR USE. RERUN THE ASSAY WITH FRESH QUALITY CONTROL SAMPLES. IF NECESSARY, CONTACT YOUR LOCAL TECHNICAL SUPPORT PROVIDER OR DISTRIBUTOR FOR ASSISTANCE." THE INSTRUCTION FOR USE 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."

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOW TROPONIN QUALITY CONTROL LEVEL 3 RECOVERY ON THE ADVIA CENTAUR SYSTEM. THE ASSAY WAS RECALIBRATED WITH FRESH REAGENTS AND QUALITY CONTROL MATERIAL AND THE TROPONIN QUALITY CONTROL RECOVERED OUT OF RANGE LOW. IT WAS NOTED THAT THE CUSTOMER'S QUALITY CONTROL RANGES WERE NOT UPDATED TO THE REVISED AND PUBLISHED MANUFACTURER'S QUALITY CONTROL RANGES FOR THE ADVIA CENTAUR TROPONIN ASSAY, HOWEVER, AFTER UPDATING TO THE REVISED TROPONIN QUALITY CONTROL RANGES THE RESULTS STILL RECOVERED LOW. PATIENT RESULTS WERE REPEATED AND REPORTED FROM AN ALTERNATE TROPONIN TEST METHOD AND SYSTEM. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE TROPONIN QUALITY CONTROL LOW RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46784 ADVIA CENTAUR TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY, PRODUCT CODE: MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010078

    Patients

    Seq Age Sex Outcome Treatment
    1