BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3901012 · Received June 30, 2014

    Report

    Report Number
    2432235-2014-00399
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 4, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 REPLACED THE WASH BLOCKS AND ASPIRATE PROBE GUIDES. CALIBRATIONS AND QUALITY CONTROLS WERE RUN, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS RELATED TO MALFUNCTIONS OF THE WASH BLOCKS AND ASPIRATE PROBE GUIDES. 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 ONE PATIENT SAMPLE ON ONE OF TWO REPLICATES ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FIVE TIMES ON THE SAME INSTRUMENT AND ONCE ON AN ALTERNATE INSTRUMENT, RESULTING LOWER. THE CORRECTED RESULT WAS REPORTED TO THE PHYSICIAN(S). 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
    380005 ADVIA CENTAUR XP CLINICAL CHEMISTRY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1