BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 4141261 · Received October 3, 2014

    Report

    Report Number
    2432235-2014-00578
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. THE CSE EVALUATED THE INSTRUMENT AND INSTRUMENT DATA AND REPLACED THE ASPIRATE RINSE BLOCK. THE CSE ALSO CLEANED THE IONIZER FAN AND RAN A PRECISION TEST. THE CAUSE OF THE DISCORDANT TNI UL RESULT IS UNKNOWN. THE CSE SUCCESSFULLY RAN CALIBRATIONS AND QUALITY CONTROLS. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED CARDIAC TROPONIN I (TNI UL) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT TNI UL RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED ON THE SAME SYSTEM, WHICH RESULTED LOWER. THE SAMPLE WAS RE-SPUN AND REPEATED TWO TIMES ON THE SAME SYSTEM. IT IS UNKNOWN AS TO WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSELY ELEVATED, TNI UL RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620405 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1