BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY

    MDR report key: 1952137 · Received December 29, 2010

    Report

    Report Number
    1219913-2010-00165
    Event Type
    Other
    Date Received
    December 29, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 10, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CAUSE FOR THE DISCORDANT ESTRADIOL-6 III RESULT IS UNKNOWN. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A DISCORDANT ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY RESULT WAS OBTAINED ON A PATIENT SAMPLE. THE INITIAL RESULT WAS QUESTIONED BY THE PHYSICIAN. REPEAT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND THE RESULT WAS HIGHER. A REDRAW PATIENT SAMPLE WAS OBTAINED AND TESTED. THE RESULT WAS HIGHER THAN THE INITIAL RESULT. PATIENT TREATMENT WAS NOT PRESCRIBED OR ALTERED. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL-6 III RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY E2-6 III IMMUNOASSAY CHP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1