BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 4130051 · Received September 30, 2014

    Report

    Report Number
    2432235-2014-00563
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 5, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00563 WAS FILED ON SEPTEMBER 30, 2014. ADDITIONAL INFORMATION (09/11/2014): A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CLEANED THE LUMINOMETER AND PHOTOMULTIPLIER TUBE DISK. THE CSE RAN TROPONIN DILUTIONS WHICH RESULTED AS EXPECTED AND ADJUSTED THE CALIBRATION OF THE REAGENT NEEDLE. NO OTHER DISCORDANT RESULTS WERE OBTAINED ON THE INSTRUMENT. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD APPLICATION SPECIALIST (FAS) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FAS PERFORMED PRECISION TESTING, RESULTING WITHIN RANGE. QUALITY CONTROLS WERE WITHIN RANGE AT THE TIME OF EVENT. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON THE THIRD OF FOUR SAMPLE DRAWS OBTAINED FROM ONE PATIENT ON AN ADVIA CENTAUR CP INSTRUMENT. IT IS UNKNOWN WHICH RESULTS WERE REPORTED TO THE PHYSICIAN(S). ALL SAMPLES WERE TESTED ON THE SAME INSTRUMENT, RESULTING LOWER THAN THE THIRD DRAW. THE CUSTOMER ALSO PERFORMED REPEAT TESTING OF THE FIRST DRAW, AND THE RESULT MATCHED THOSE OF THE OTHER SAMPLES. THE NEXT DAY, THE CUSTOMER PERFORMED REPEAT TESTING OF THREE DRAWS ON THE SAME INSTRUMENT, ALL RESULTS MATCHED. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607249 ADVIA CENTAUR CP CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1