BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3171227 · Received June 14, 2013

    Report

    Report Number
    2432235-2013-00275
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 20, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    LOM
    PMA / PMN Number
    K041133
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 DID NOT FIND AN INSTRUMENT MALFUNCTION. THE FSE RAN QUALITY CONTROLS, ALL OF WHICH WERE WITHIN RANGE. THE SECOND SAMPLE TUBE FROM THE PATIENT HAD RESULTED AS EXPECTED ON THE SAME INSTRUMENT PRIOR TO SERVICE. THE CAUSE OF THE DISCORDANT, FALSE POSITIVE HBSAG RESULTS ON ONE PATIENT SAMPLE IS UNKNOWN. THE INSTRUMENT IS PERFORMING ACCORDING TO SPECIFICATIONS. NO FURTHER EVALUATION OF THIS DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT, FALSE POSITIVE HEPATITIS B SURFACE ANTIGEN (HBSAG) RESULTS WERE OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE SAMPLE HAD BEEN RUN AND INITIALLY RESULTED NEGATIVE. UPON REPEAT TESTING, THE SAMPLE RESULTED POSITIVE. THE SAMPLE WAS RERUN A SECOND TIME IN DUPLICATE ON THE SAME INSTRUMENT AND BOTH REPLICATES ALSO RESULTED POSITIVE. THE DISCORDANT RESULTS WERE NOT REPORTED TO THE PHYSICIAN(S). A DIFFERENT SAMPLE TUBE FROM THE SAME PATIENT WAS THEN RUN ON THE SAME INSTRUMENT AND RESULTED NEGATIVE, MATCHING THE INITIAL RESULT. THE NEGATIVE RESULT WAS REPORTED TO THE PHYSICIAN(S). THERE ARE NO KNOWN REPORTS OF PATIENT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT, FALSE POSITIVE HBSAG RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271410 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER LOM SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1