BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3864211 · Received June 10, 2014

    Report

    Report Number
    2432235-2014-00369
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 16, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR 2432235-2014-00369 WAS FILED ON JUNE 11, 2014.ADDITIONAL INFORMATION (05/16/2014): THE ADVIA CENTAUR CP SERIAL NUMBER (B)(4) WAS REMOVED FROM THE SITE AND REPLACED WITH AN ADVIA CENTAUR XP. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UKNOWN.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER CONTACTED THE SIEMENS TECHNICAL SOLUTIONS CENTER (TSC). THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS UNKNOWN. SIEMENS IS INVESTIGATING THIS ISSUE.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON ONE OF TWO SAMPLES DRAWN FROM THE SAME PATIENT ON AN ADVIA CENTAUR CP INSTRUMENT. THE FIRST SAMPLE WAS RUN AND RESULTED AS EXPECTED. THE SECOND PATIENT SAMPLE WAS RUN ON THE SAME INSTRUMENT, RESULTING FALSELY HIGH. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED IN AN ALTERNATE LABORATORY, 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
    338109 ADVIA CENTAUR CP CLINICAL CHEMISTRY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1