BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TROPONIN ULTRA ASSAY

    MDR report key: 3784692 · Received May 1, 2014

    Report

    Report Number
    1219913-2014-00104
    Event Type
    Malfunction
    Date Received
    May 1, 2014
    Date of Event
    April 4, 2014
    Report Date
    April 8, 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

    THE CAUSE OF THE DISCORDANT RESULTS APPEARS TO BE RELATED TO A SPECIFIC ADVIA CENTAUR TNI ULTRA REAGENT PACK (PACK ID (B)(4)) FROM REAGENT LOT 010079. THE QUALITY CONTROL RESULTS WERE WITHIN RANGE WHEN TESTED ON THE PACK AT 9:22 AM, HOWEVER THEY WERE OUT OF RANGE WHEN TESTED AGAIN. THIS INDICATES THAT A CHANGE OCCURRED TO THE REAGENTS WHILE THE REAGENTS WERE ONBOARD THE SYSTEM. A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT ON SITE AND DID NOT OBSERVE ANY ISSUES WITH THE SYSTEM. THE FSE STATED THAT THERE WAS NO EVIDENCE OF CONTAMINATION OF THE SYSTEM. THE FSE NOTED THAT THE SOLID PHASE REAGENT APPEARED TO HAVE A SUSPENSION ON THE BOTTOM OF THE PACK THAT WAS NOT OBSERVED ON OTHER PACKS. THE CUSTOMER HAS NOT REPORTED ANY ADDITIONAL PROBLEMS SINCE REPLACING THE REAGENT PACK. SIEMENS HAS REQUESTED THAT THE PACK BE SENT TO SIEMENS FOR TESTING. THE SUMMARY AND EXPLANATION OF THE TEST SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES: "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 INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00104 ON APRIL 8, 2014 FOR TWO FALSELY ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULTS WITH A REAGENT PACK. MAY 29, 2014 - ADDITIONAL INFORMATION: SIEMENS REQUESTED THAT THE REAGENT PACK THAT WAS USED TO GENERATE THE FALSELY ELEVATED RESULTS BE SENT TO SIEMENS FOR TESTING. HOWEVER, THE REAGENT PACK WILL NOT BE RETURNED SINCE IT HAS BEEN OPENED FOR TWO MONTHS. NO FURTHER INVESTIGATION IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED ADVIA CENTAUR XP TROPONIN ULTRA (TNI ULTRA) RESULTS WERE OBSERVED ON TWO PATIENT SAMPLES WITH A REAGENT PACK. THE SAMPLES RESULTED AS NEGATIVE UPON REPEAT TESTING WITH A DIFFERENT REAGENT PACK. ADDITIONAL TESTING OF QUALITY CONTROL MATERIAL ON THE REAGENT IN QUESTION WERE OUT OF RANGE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED BASED ON THE DISCORDANT RESULT. THERE ARE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES BASED ON THE FALSELY ELEVATED ADVIA CENTAUR XP TNI ULTRA RESULT. THERE ARE NO REPORTS THAT PATIENT RESULTS WERE DELAYED DUE TO THE OUT OF RANGE CONTROL VALUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261226 ADVIA CENTAUR XP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010079

    Patients

    Seq Age Sex Outcome Treatment
    1