BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA

    MDR report key: 3917197 · Received July 7, 2014

    Report

    Report Number
    1219913-2014-00166
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00166 ON JUNE 12, 2014 REPORTING THREE ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA RESULTS THAT WERE NOT REPRODUCIBLE UPON REPEAT TESTING. NOVEMBER 11, 2014, CORRECTION: THE ORIGINAL MDR REPORTED THAT THE EVENT OCCURRED WITH ADVIA CENTAUR CP TROPONIN ULTRA LOT 010083, HOWEVER, THE CUSTOMER CONFIRMED THAT ADVIA CENTAUR CP TROPONIN ULTRA LOT 010084 EXPIRATION DATE DECEMBER 28, 2014 WAS IN USE AT THE TIME OF THE EVENT. ADDITIONAL INFORMATION SIEMENS FIELD SERVICE ENGINEER DID NOT IDENTIFY ANY ISSUES WITH THE INSTRUMENT WHICH WOULD CAUSE THE DISCORDANT RESULTS. TROUBLESHOOTING WAS PERFORMED WITH ADVIA CENTAUR CP TROPONIN ULTRA REAGENT LOTS 010084 AND 010086. NO CONCLUSIONS CAN BE DRAWN. THE CUSTOMER IS CURRENTLY USING ADVIA CENTAUR CP TROPONIN ULTRA REAGENT LOT 010087. THE SYSTEM IS PERFORMING TO SPECIFICATION. NO FURTHER INVESTIGATION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED TO SIEMENS THAT THREE PATIENT SAMPLES HAD POSITIVE ADVIA CENTAUR CP TNI ULTRA RESULTS THAT DID NOT CONFIRM WITH REPEAT TESTING, HOWEVER, INFORMATION REGARDING PATIENT SID (B)(6) WAS THE ONLY INFORMATION PROVIDED. THE CAUSE OF THE NON REPRODUCIBLE RESULTS IS UNKNOWN. SIEMENS WENT ON SITE AND REPLACED THE RING MAGNET AND THE SLIDE BEARING WERE REPLACED. NO CONCLUSIONS CAN BE DRAWN. THE SUMMARY AND EXPLANATION OF THE TEST SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "ALWAYS ANALYZE CTNI RESULTS IN THE CONTEXT OF TIME ELAPSED SINCE PATIENT PRESENTATION TO THE HOSPITAL. SERIAL SAMPLE 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 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 NOTIFIED SIEMENS THAT THERE WERE THREE ELEVATED ADVIA CENTAUR CP TROPONIN ULTRA (TNI ULTRA) RESULTS THAT WERE NOT REPRODUCIBLE UPON REPEAT TESTING. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE NON-REPRODUCIBLE RESULTS. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THE FALSELY ELEVATED ADVIA CENTAUR CP TNI ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394837 ADVIA CENTAUR CP TROPONIN ULTRA TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010083

    Patients

    Seq Age Sex Outcome Treatment
    1