BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY

    MDR report key: 1869077 · Received October 6, 2010

    Report

    Report Number
    1219913-2010-00115
    Event Type
    Other
    Date Received
    October 6, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 10, 2010
    Manufacturer
    SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS, INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 UNKNOWN. 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 PATIENT SAMPLE. THE INITIAL RESULT WAS REPORTED TO THE PHYSICIAN. THE PHYSICIAN QUESTIONED THE RESULT AND REQUESTED THE TEST TO BE REPEATED. REPEAT TESTING WAS PERFORMED ON THE PATIENT SAMPLE AND A CORRECTED REPORT WAS ISSUED. 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 MEDICAL SOLUTIONS DIAGNOSTICS, INC. NA 134

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR