BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3974209 · Received August 1, 2014

    Report

    Report Number
    2432235-2014-00459
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 7, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE CSE CLEANED THE IONIZER FAN AND REPLACED THE REAGENT PROBE, ACID PORT AND WASH 1 BOTTLE. THE CSE ALIGNED THE PROBES AND RAN QUALITY CONTROLS WHICH RESULTED WITHIN RANGE. THE CAUSE OF THE SIGNAL ERRORS ON TROPONIN PATIENT SAMPLES IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    AN OPERATOR OF AN ADVIA CENTAUR CP INSTRUMENT STATED THAT SIGNAL ERRORS WERE OBTAINED ON PATIENT SAMPLES TESTED FOR TROPONIN. NO DISCORDANT RESULTS WERE GENERATED ON THE SAMPLES. THERE ARE NO REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE SIGNAL ERRORS ON TROPONIN PATIENT SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449707 ADVIA CENTAUR CP CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1