BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY

    MDR report key: 1891003 · Received November 1, 2010

    Report

    Report Number
    1219913-2010-00128
    Event Type
    Other
    Date Received
    November 1, 2010
    Date of Event
    October 4, 2010
    Report Date
    October 13, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DISCORDANT ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY RESULTS WERE OBTAINED ON A PT SAMPLE. THE INITIAL RESULTS WERE QUESTIONED BECAUSE THE RESULTS DID NOT MATCH THE CLINICAL PICTURE. REPEAT TESTING WAS PERFORMED ON THE PT SAMPLE AND THE RESULT RELEASED. PT 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 134

    Patients

    Seq Age Sex Outcome Treatment
    1