BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1872386 · Received October 13, 2010

    Report

    Report Number
    2432235-2010-00143
    Event Type
    Other
    Date Received
    October 13, 2010
    Date of Event
    September 26, 2010
    Report Date
    September 26, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS
    Product Code
    MOI
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. THE FSE DID A FUNCTIONAL SYSTEM CHECK AND FOUND A BUBBLE UNDER THE WASH DISPLACEMENT PORT. HE REMOVED THE BUBBLE AND FOUND NO OTHER ISSUES. THE FSE RAN CALIBRATORS AND QC, THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. IT IS NOT KNOWN IF THE BUBBLE CAUSED THE DISCREPANT RESULT. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR XP BNP RESULT WAS OBTAINED ON A PT SAMPLE. THE LABORATORY ORIGINALLY GOT A HIGH BNP RESULT WHICH THEY DILUTED ON-SYSTEM WITH MIXED RESULTS. THE CUSTOMER THEN REPEATED THE DILUTIONS MANUALLY AND ON-SYSTEM. THE MANUAL DILUTION RESULTS CORRELATED BETTER THAN THE ON-SYSTEM RESULTS. THE INITIAL HIGH RESULT WAS REPORTED TO THE EMERGENCY ROOM PHYSICIAN. THERE WAS NO REPORT OF PT INTERVENTION OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT BNP RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNOASSAY ANALYZER MOI SIEMENS HEALTHCARE DIAGNOSTICS ADVIA CENTAUR XP NA

    Patients

    Seq Age Sex Outcome Treatment
    1