BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TNI-ULTRA ASSAY

    MDR report key: 7582314 · Received June 8, 2018

    Report

    Report Number
    1219913-2018-00172
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 23, 2018
    Report Date
    August 1, 2018
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    UDI-DI
    00630414516226
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SIEMENS FILED MDR ON 06/08/2018 FOR FALSE LOW ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A COMPARISON OF REAGENT LOT: (010128) TO A NEWER REAGENT LOT: (010132) RECEIVED. 07/16/2018: ADDITIONAL INFORMATION: SIEMENS REVIEWED PATIENT SAMPLES RUN AT QUALITY CONTROL (QC) RELEASE FOR LOT: 010132, AND THE RESULTS MET SPECIFICATIONS. PATIENT SAMPLES WERE RUN ON ADVIA CENTAUR XP TNI-ULTRA REAGENT LOTS: 010127 - 010132, AND THE 99TH% REFERENCE RANGE WAS VERIFIED. THE LOWER PATIENT RESULTS OBSERVED CAN BE ATTRIBUTED TO REAGENT LOT TO REAGENT LOT VARIABILITY. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THE FALSELY LOW ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) COMPARISON RESULTS OBSERVED BY THE CUSTOMER WITH REAGENT LOT 010132 IS BEING INVESTIGATED BY SIEMENS. 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."

    Description of Event or Problem · 1

    THE CUSTOMER OBSERVED FALSELY LOW ADVIA CENTAUR XP CARDIAC TROPONIN I (TNI-ULTRA) PATIENT RESULTS WHEN PERFORMING A COMPARISON OF REAGENT LOT (010128) TO A NEWER REAGENT LOT (010132) RECEIVED. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES DUE TO THE LOW ADVIA CENTAUR XP TNI-ULTRA RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425374 ADVIA CENTAUR XP TNI-ULTRA ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010132 00630414516226

    Patients

    Seq Age Sex Outcome Treatment
    1