BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVIA CENTAUR XP CORTISOL (COR) ASSAY

    MDR report key: 3036128 · Received April 4, 2013

    Report

    Report Number
    1219913-2013-00075
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 14, 2013
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS, INC.
    Product Code
    JFT
    PMA / PMN Number
    K962559
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE AND PERFORMED A FULL SYSTEM INSPECTION. THE SYSTEM WAS FULLY FUNCTIONAL. NO CONCLUSION CAN BE DRAWN. THE CAUSE FOR THE DISCORDANT CORTISOL 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 CORTISOL RESULTS WERE OBTAINED FOR TWO SAMPLES FROM THE SAME PATIENT. THE SAMPLES WERE TESTED 30 MINUTES APART. THE RESULTS WERE QUESTIONED BY THE PHYICIAN. REPEAT TESTING WAS PERFORMED ON BOTH SAMPLES. ONE RESULT WAS SIMILAR TO THE INITIAL RESULT AND ONE RESULT WAS HIGHER THAN THE INITIAL RESULT. IT IS UNKNOWN IF PATIENT TREATMENT WAS PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT CORTISOL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138846 ADVIA CENTAUR XP CORTISOL (COR) ASSAY CORTISOL IMMUNOASSAY JFT SIEMENS HEALTHCARE DIAGNOSTICS, INC. N/A 260

    Patients

    Seq Age Sex Outcome Treatment
    1