BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 4133769 · Received October 1, 2014

    Report

    Report Number
    2432235-2014-00571
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 6, 2014
    Report Date
    September 6, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 PROBE ASSEMBLY, ASPIRATE WASHER TUBING ASSEMBLY AND THE WASH STATION BUBBLE DETECTOR SENSOR. THE CAUSE OF THE DISCORDANT TNI UL RESULT IS UNKNOWN. THE CUSTOMER SUCCESSFULLY RAN 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 REPORTED TO THE PHYSICIAN(S), WHO SENT THE PATIENT TO THE CATHETERIZATION LAB. THE SAMPLE WAS REPEATED TWO TIMES ON THE SAME SYSTEM, WHICH RESULTED LOWER. THE CUSTOMER ALSO REPEATED THE SAME SAMPLE TWO TIMES ON AN ALTERNATE SYSTEM, WHICH RESULTED LOWER. THE LABORATORY SENT THE CORRECTED RESULT TO THE PHYSICIAN(S), WHO CANCELLED THE CATHETERIZATION LAB PROCEDURE. IT IS UNKNOWN AS TO WHICH REPEAT RESULT WAS REPORTED TO THE PHYSICIAN(S) AS THE CORRECTED RESULT. 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
    611647 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1