BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 3791496 · Received May 5, 2014

    Report

    Report Number
    2432235-2014-00321
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 11, 2014
    Report Date
    April 10, 2014
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    NHS
    PMA / PMN Number
    K971418
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS CUSTOMER SERVICE ENGINEER (CSE) WAS DISPATCHED TO THE CUSTOMER SITE TO EVALUATE THE INSTRUMENT AND INSTRUMENT DATA. THE CSE DISCOVERED REAGENT PROBE 1 DISPLAYED SYSTEM ERRORS WHEN COMMENCING FAULT FINDING FOR THE CHIV ASSAY PROBLEM. THE CSE REMOVED THE REAGENT PROBE 1 ASSEMBLY AND CLEANED THE IN-OUT OPTICAL SENSOR ARRAY. THE CSE ALSO REPLACED A FAULTY SEPARATION MANIFOLD AND PERFORMED A TOTAL SERVICE CALL ON THE INSTRUMENT. THE CSE WAS INVOLVED WITH EXTENSIVE TROUBLESHOOTING, WHICH REQUIRED MULTIPLE CUSTOMER SITE VISITS. THE CAUSE OF THE DISCORDANT CHIV RESULT IS UNKNOWN. THE CSE SUCCESSFULLY RAN CALIBRATIONS AND QC. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. FURTHER EVALUATION OF THE DEVICE IS NOT REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT, FALSE NEGATIVE C HUMAN IMMUNOVIRUS (CHIV) RESULT WAS OBTAINED ON ONE PATIENT SAMPLE ON AN ADVIA CENTAUR XP INSTRUMENT. THE DISCORDANT CHIV RESULT WAS REPORTED TO THE PHYSICIAN(S). THE SAMPLE WAS REPEATED FOUR TIMES ON AN ALTERNATE INSTRUMENT. IT IS UNKNOWN WHAT REPEAT RESULTS WERE REPORTED TO THE PHYSICIAN(S). THERE WERE NO REPORTS OF ADVERSE HEALTH CONSEQUENCES OR KNOWN PATIENT INTERVENTION DUE TO THE DISCORDANT CHIV RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266455 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER NHS SIEMENS HEALTHCARE DIAGNOSTICS INC. ADVIA CENTAUR XP

    Patients

    Seq Age Sex Outcome Treatment
    1