BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR

    MDR report key: 3113371 · Received May 15, 2013

    Report

    Report Number
    2432235-2013-00177
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 18, 2013
    Report Date
    April 19, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    JJE
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER WAS DISPATCHED TO THE CUSTOMER SITE. AFTER EVALUATION OF THE INSTRUMENT AND INSTRUMENT DATA, THE FSE DISCOVERED A PIN-HOLE SIZED LEAK IN THE ACID PROBE TUBING. THE FSE TRIMMED THE DAMAGED END OF THE ACID PROBE TUBING AND VERIFIED THAT THE ACID DISPENSE WAS NO LONGER LEAKING. SIX ASSAYS WERE CALIBRATED ON THE INSTRUMENT, ALL OF WHICH PASSED, AND QUALITY CONTROLS WERE RUN AND ALL WERE WITHIN RANGE. THE CAUSE OF THE DISCORDANT, FALSELY LOW FERRITIN RESULT WAS THE LEAK IN THE ACID PROBE TUBING. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSELY LOW FERRITIN RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR INSTRUMENT. THE DISCORDANT RESULT WAS REPORTED TO THE PHYSICIAN(S). THE OPERATOR HAD PERFORMED A QUALITY CONTROL RUN, AND QUALITY CONTROLS WERE OUT OF RANGE. THE OPERATOR RERAN SAMPLES FROM THE PREVIOUS SHIFT ON AN ALTERNATE INSTRUMENT AND ONE FERRITIN SAMPLE RESULTED HIGHER. IT IS UNKNOWN IF QUALITY CONTROLS WERE WITHIN RANGE WHEN THE DISCORDANT RESULT WAS OBTAINED. 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 LOW FERRITIN RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214046 ADVIA CENTAUR IMMUNOASSAY ANALYZER JJE SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR

    Patients

    Seq Age Sex Outcome Treatment
    1