BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR TESTOSTERONE (TSTO)

    MDR report key: 1300614 · Received January 30, 2009

    Report

    Report Number
    1219913-2009-00008
    Event Type
    Other
    Date Received
    January 30, 2009
    Date of Event
    January 16, 2009
    Report Date
    January 22, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC
    Product Code
    CDZ
    PMA / PMN Number
    K934562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 TESTOSTERONE RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A FALSELY DEPRESSED ADVIA CENTAUR TESTOSTERONE RESULT WAS OBTAINED ON A PATIENT SAMPLE AND REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT. REPEAT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND THE TEST RESULT WAS HIGHER. A CORRECTED REPORT WAS ISSUED TO THE PHYSICIAN. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT TESTOSTERONE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR TESTOSTERONE (TSTO) TESTOSTERONE IMMUNOASSAY CDZ SIEMENS HEALTHCARE DIAGNOSTICS, INC NA 139

    Patients

    Seq Age Sex Outcome Treatment
    1