BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR CP

    MDR report key: 3191527 · Received June 26, 2013

    Report

    Report Number
    2432235-2013-00290
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    MMI
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED A PINHOLE-SIZED LEAK IN THE TUBING NEAR ASPIRATE PROBE 1, WHICH HAD PREVENTED THE PROBE FROM COMPLETELY ASPIRATING LIQUID FROM THE CUVETTES. THE FSE TRIMMED THE TUBING AND PERFORMED A BUBBLE SENSOR CALIBRATION, THEN VERIFIED PROPER ASPIRATION OF THE LIQUID. THE SYSTEM WAS CALIBRATED AND QUALITY CONTROLS WERE RUN, ALL OF WHICH WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS THE PINHOLE-SIZED LEAK IN THE TUBING NEAR ASPIRATE PROBE 1. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY ELEVATED TROPONIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR CP INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S), WHO QUESTIONED THE RESULT. THE SAMPLE WAS RERUN ON AN ALTERNATE INSTRUMENT AND RESULTED LOWER. THE RERUN RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN 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
    291548 ADVIA CENTAUR CP IMMUNOASSAY ANALYZER MMI SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR CP

    Patients

    Seq Age Sex Outcome Treatment
    1