BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR TROPONIN ULTRA (TNI ULTRA) ASSAY

    MDR report key: 4028327 · Received August 21, 2014

    Report

    Report Number
    1219913-2014-00218
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 30, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    MMI
    PMA / PMN Number
    K053020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SIEMENS SUBMITTED THE INITIAL MDR 1219913-2014-00218 ON JULY 30, 2014 REPORTING ELEVATED ADVIA CENTAUR TROPONIN ULTRA RESULTS FOR SEVEN SAMPLES FROM THE SAME PATIENT. SEPTEMBER 23, 2014 - ADDITIONAL INFORMATION. SIEMENS RECEIVED THREE SAMPLES FROM THE PATIENT. THE SAMPLES WERE TESTED NEAT, 1:2 AND 1:5 DILUTED AND WITH HETEROPHILE BLOCKING TUBES (HBT). THE RESULTS WITH HBT WERE NOT SIGNIFICANTLY LOWER INDICATING THESE SAMPLES ARE NOT CONFIRMED FOR HETEROPHILE/HAMA. THE DILUTED RESULTS WERE LOWER. THE 1:5 RESULT WAS CONSIDERABLY LOWER THAN THE NEAT RESULT INDICATING THERE IS A NON-SPECIFIC INTERFERENT IN THE SAMPLES. THE PATIENT WAS TREATED WITH KEYHOLE LIMPET HEMOCYANIN (KLH). KLH S NOT A DRUG THAT HAS BEEN TESTED ON THE ADVIA CENTAUR TROPONIN ULTRA ASSAY TO DETERMINE IF IT CAUSES INTERFERENCE.

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR TROPONIN ULTRA RESULTS IS UNKNOWN. THE ISSUE APPEARS TO BE SPECIFIC TO THE PATIENT SINCE MULTIPLE SAMPLES FROM THE SAME PATIENT SHOW ELEVATED RESULTS. THE ISSUE DOES NOT APPEAR TO BE RELATED TO THE SPECIFIC ADVIA CENTAUR SINCE THE RESULT FROM AN ADVIA CENTAUR AT A DIFFERENT SITE SHOWS A SIMILAR RESULT. QUALITY CONTROL RESULTS ARE WITHIN THE CUSTOMER'S RANGES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED. SIEMENS HAS REQUESTED THE SAMPLES FOR INTERNAL TESTING. 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 O...

    Description of Event or Problem · 1

    CUSTOMER OBSERVED ELEVATED ADVIA CENTAUR TROPONIN ULTRA RESULTS FOR SEVEN SAMPLES FROM THE SAME PATIENT COMPARED TO CLINICAL CONDITIONS. THERE ARE NO REPORTS THAT TREATMENT WAS ALTERED OR PRESCRIBED OR ADVERSE HEALTH CONSEQUENCES BASED ON THE ELEVATED RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507360 ADVIA CENTAUR TROPONIN ULTRA (TNI ULTRA) ASSAY TROPONIN IMMUNOASSAY MMI SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 010084

    Patients

    Seq Age Sex Outcome Treatment
    1