BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP TESTOSTERONE (TSTO) ASSAY

    MDR report key: 2785029 · Received October 12, 2012

    Report

    Report Number
    1219913-2012-00369
    Event Type
    Malfunction
    Date Received
    October 12, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 19, 2012
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    CDZ
    PMA / PMN Number
    K934562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ADVIA CENTAUR XP TESTOSTERONE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATION. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    LOW ADVIA CENTAUR XP TESTOSTERONE TEST RESULTS WERE OBTAINED BY THE CUSTOMER AND CONSIDERED DISCORDANT WHEN COMPARED WITH A REDRAW PATIENT SAMPLE TEST RESULT. THERE WAS NO REPORT OF PATIENT TREATMENT BEING PRESCRIBED OR ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ADVIA CENTAUR XP TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR XP TESTOSTERONE (TSTO) ASSAY TESTOSTERONE IMMUNOASSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 157

    Patients

    Seq Age Sex Outcome Treatment
    1