BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY

    MDR report key: 1610916 · Received February 16, 2010

    Report

    Report Number
    1219913-2010-00019
    Event Type
    Other
    Date Received
    February 16, 2010
    Date of Event
    January 28, 2010
    Report Date
    February 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 ESTRADIOL-6 III RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECIFICATIONS. NO FURTHER EVALUATION 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 NEAT RESULTS FOR ESTRADIOL-6 III DID NOT MATCH THE 1:5 DILUTED RESULTS. 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 131

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR