BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP TROPONIN ULTRA ASSAY

    MDR report key: 3607393 · Received February 5, 2014

    Report

    Report Number
    1219913-2014-00015
    Event Type
    Malfunction
    Date Received
    February 5, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2014-00015 ON FEBRUARY 5, 2014 FOR A LOW QUALITY CONTROL BIAS WITH ADVIA CENTAUR CP TNI ULTRA REAGENT LOT 010078. ON APRIL 4, 2014 - ADDITIONAL INFORMATION: INITIALLY, A LOW QUALITY CONTROL RECOVERY WAS OBSERVED WITH THE ADVIA CENTAUR CP TNI ULTRA REAGENT LOT 010078. AFTER INVESTIGATION, SIEMENS PROVIDED THE CONTROL MANUFACTURER WITH UPDATED QUALITY CONTROL (QC) LOTS 29810 AND 29820 INSERT VALUES AND RANGES ON THE ADVIA CENTAUR XP TNI ULTRA REAGENT LOT 010078 AND LOWER. THE CUSTOMER'S QUALITY CONTROL RECOVERY IS WITHIN THE UPDATED PUBLISHED QC RANGES AND PATIENT RESULTS ARE BEING REPORTED ON THE ADVIA CENTAUR CP SYSTEM. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. MANUFACTURER'S INSERT UPDATES FOR USE WITH ADVIA CENTAUR TNI ULTRA LOT 010078 AND LOWER: VALUES ARE PROVIDED IN NG/ML. (B)(4).

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM INSPECTION. THE FSE CHECKED THE ACID AND BASE PUMPS AND LUMINOMETER. ALL WERE ACCEPTABLE. THE FSE ALSO DECONTAMINATED THE SYSTEM, RECALIBRATED THE TNI ULTRA ASSAY AND RAN QUALITY CONTROL MATERIAL (QC) AND FOUND RESULTS TO BE ACCEPTABLE. THE SYSTEM WAS OPERATIONAL UPON DEPARTURE. DURING TROUBLESHOOTING OF THE LOW CONTROL RECOVERY, THE CUSTOMER USED A DIFFERENT SYSTEM TO GENERATE TROPONIN I RESULTS. SIEMENS CONTINUES T TROUBLESHOOT THE CONTROL BIAS. THE QUALITY CONTROL SECTION OF THE INSTRUCTIONS FOR USE (IFU) 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 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 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 SYSTEM IS PERFORMING WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED LOW RESULTS FOR BIO-RAD CARDIAC MARKER PLUS QUALITY CONTROL MATERIAL LOT 29810 ON THE ADVIA CENTAUR CP TNI-ULTRA ASSAY LOT 010078. CUSTOMER STATED THAT THE CONTROLS WERE LOW COMPARED TO TARGET AND OUT OF RANGE. THERE WAS NO KNOWN REPORT OF PATIENT TREATMENT BEING ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW RECOVERY OF THE QUALITY CONTROL MATERIAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74947 ADVIA CENTAUR CP TROPONIN ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010078

    Patients

    Seq Age Sex Outcome Treatment
    1