BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP AFP ASSAY

    MDR report key: 2417010 · Received January 16, 2012

    Report

    Report Number
    1219913-2012-00009
    Event Type
    Malfunction
    Date Received
    January 16, 2012
    Date of Event
    December 6, 2011
    Report Date
    December 27, 2011
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    LOJ
    PMA / PMN Number
    K020806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT AFP RESULTS IS UNKNOWN. POSSIBLE CAUSE IS HETEROPHILE INTERFERENCES OR EXOGENOUS INTERFERENCES. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT LOW ADVIA CENTAUR XP AFP RESULTS WERE OBTAINED FOR SAMPLES FROM ONE PATIENT. THE RESULTS WERE DISCORDANT WITH THE DILUTION TESTING AND PREVIOUS RESULTS. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT AFP RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP AFP ASSAY AFP IMMUNOASSAY LOJ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 136

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR