BEUDAMED
    FDA Adverse Event Summary report: N

    ADVIA CENTAUR XP CA 19-9 ASSAY

    MDR report key: 2062413 · Received April 19, 2011

    Report

    Report Number
    1219913-2011-00053
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    NIG
    PMA / PMN Number
    K031393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE. ANALYSIS OF THE INSTRUMENT AND INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR CA19-9 RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR XP CA 19-9 RESULTS WERE OBTAINED ON A PATIENT SAMPLE. THE NEAT AND DILUTED RESULTS DID NOT MATCH. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CA 19-9 RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP CA 19-9 ASSAY CA 19-9 IMMUNOASSAY NIG SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 091

    Patients

    Seq Age Sex Outcome Treatment
    1