BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP ANTI-TPO (ATPO) ASSAY

    MDR report key: 2441384 · Received February 7, 2012

    Report

    Report Number
    1219913-2012-00045
    Event Type
    Malfunction
    Date Received
    February 7, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 9, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JZO
    PMA / PMN Number
    K003291
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ANTI-TPO (ATPO) RESULTS IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    DISCORDANT HIGH ADVIA CENTAUR XP ANTI-TPO (ATPO) RESULTS WERE OBTAINED FOR A PATIENT SAMPLE. THE RESULTS WERE DISCORDANT WITH AN ALTERNATE METHOD. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ANTI-TPO RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP ANTI-TPO (ATPO) ASSAY ANTI-TPO (ATPO) IMMUNOASSAY JZO SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 188

    Patients

    Seq Age Sex Outcome Treatment
    1