BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TNI-ULTRA ASSAY

    MDR report key: 6968409 · Received October 23, 2017

    Report

    Report Number
    1219913-2017-00218
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    September 16, 2017
    Report Date
    October 23, 2017
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    00630414516226
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS TESTED A TNI-ULTRA REAGENT READYPACK OF LOT 010121 (CUSTOMER COMPLAINT LOT) WITH A LOW LEVEL CARDIAC QUALITY CONTROL (BIORAD), AND A NEGATIVE PATIENT SAMPLE POOL. THE TEST SAMPLES WERE RUN ON A FULL VOLUME REAGENT READYPACK, AND SUBSEQUENTLY ON A LOW VOLUME REAGENT READYPACK. THERE WAS NO OBSERVED INCREASE IN TNI-ULTRA RESULTS AS THE PACK VOLUME DECREASED. A SIEMENS CUSTOMER SERVICE ENGINEER (CSE), AND SIEMENS TECHNICAL APPLICATION REPRESENTATIVE HAVE PREVIOUSLY BEEN AT THE CUSTOMER SITE, AND FOUND NO SYSTEM OR LOW VOLUME TNI-ULTRA REAGENT READYPACK ISSUES OBSERVED BY THE CUSTOMER. THE CAUSE OF THE FALSELY ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS MAY BE ATTRIBUTED TO REAGENT HANDLING/STORAGE. NO CONCLUSION 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 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 INTERPRETATION OR RESULTS SECTION OF THE INSTRUCTION FOR USE STATES THE FOLLOWING: "RESULTS OF THIS ASSAY SHOULD ALWAYS BE INTERPRETED IN CONJUNCTION WITH PATIENT'S MEDICAL HISTORY, CLINICAL PRESENTATION AND OTHER FINDINGS." THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    SIEMENS FILED THE INITIAL MDR 1219913-2017-00218 ON 10/23/2017 FOR FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) RESULTS OBSERVED BY THE CUSTOMER WHEN PERFORMING A REAGENT LOT CORRELATION STUDY. 10/23/17 - CORRECTION. THE DATE OF THE REPORT IS 10/23/2017, AND NOT 10/20/2017 AS INITIALLY STATED. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    FALSELY ELEVATED ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) RESULTS WERE OBSERVED BY THE CUSTOMER WHEN PERFORMING A REAGENT LOT TO NEW REAGENT LOT CORRELATION STUDY. THE PATIENT CORRELATION SAMPLES WHEN RUN ON A PREVIOUS REAGENT LOT (010121) WERE POSITIVE FOR TNI-ULTRA, AND NEGATIVE COMPARED TO THE NEW REAGENT LOT (010123). IT WAS OBSERVED BY THE CUSTOMER THAT THE REAGENT READYPACK VOLUME FOR LOT 010121 WAS LOW AT THE TIME OF THE CORRELATION RUN. THE CUSTOMER PERFORMED FURTHER TROUBLESHOOTING, RAN A STUDY (N=8) WITH THE LOW LEVEL QUALITY CONTROL MATERIAL ON A LOW VOLUME REAGENT READY PACK, AND SOME OF THE RESULTS WERE OBSERVED TO BE OUT OF RANGE. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE ELEVATED ADVIA CENTAUR XP TNI-ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748892 ADVIA CENTAUR XP TNI-ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010121 00630414516226

    Patients

    Seq Age Sex Outcome Treatment
    1