BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3910363 · Received July 2, 2014

    Report

    Report Number
    2432235-2014-00403
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 11, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 OBSERVED THAT THE ASPIRATION PROBE WASTE PUMP WAS NOT WORKING PROPERLY FOR ASPIRATION PROBE 2. THE CSE REPLACED THE PERISTALTIC PUMP TUBING AND ALL WASTE TUBING, REPLACED AND ADJUSTED THE REAGENT PROBE AND REPLACED THE WASH 1 SOLUTION. THE CSE REPLACED AND ALIGNED THE INCUBATION RING AND RAN PRECISION TESTING, RESULTING WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT IS AN INCUBATION RING MALFUNCTION. 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 DURING REPEAT TESTING ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULT WAS NOT REPORTED TO THE PHYSICIAN(S). THE SAMPLE HAD RESULTED LOWER ON INITIAL RUN AND THE DISCORDANT RESULT WAS OBTAINED ON REPEAT ON THE SAME INSTRUMENT. 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
    387766 ADVIA CENTAUR CP CLINICAL CHEMISTRY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1