BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR XP

    MDR report key: 1240881 · Received November 10, 2008

    Report

    Report Number
    2432235-2008-00135
    Event Type
    Other
    Date Received
    November 10, 2008
    Date of Event
    October 18, 2008
    Report Date
    October 20, 2008
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
    Product Code
    JJE
    PMA / PMN Number
    K971418
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCREPANT RESULTS WAS THE PRESENCE OF PARTICULATE MATTER IN THE LOWER WASH MANIFOLD. THE INSTRUMENT HAS BEEN REPAIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCREPANT ADVIA CENTAUR XP MULTIPLE INFECTIOUS DISEASE ASSAY RESULTS WERE OBTAINED. THE INITIAL RESULTS WERE REPORTED. UPON REPEAT ON A SECOND SYSTEM, CORRECT RESULTS WERE SENT OUT. THERE WAS NO PT INTERVENTION OR REPORT OF ADVERSE HEALTH CONSEQUENCE, DUE TO THE DISCREPANT RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP IMMUNO-ASSAY ANALYZER JJE SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1