BEUDAMED
    FDA Adverse Event Other Summary report: N

    ADVIA CENTAUR CP ESTRADIOL-6 III ASSAY

    MDR report key: 1707039 · Received May 26, 2010

    Report

    Report Number
    1219913-2010-00059
    Event Type
    Other
    Date Received
    May 26, 2010
    Date of Event
    May 11, 2010
    Report Date
    May 13, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SIEMENS FIELD APPLICATION SPECIALIST PERFORMED SERIAL DILUTIONS AT THE CUSTOMER SITE AND CONFIRMED THAT THE FINAL RESULT RELEASED TO THE CLINIC WAS APPROPRIATE. THE PREVIOUS RESULT FROM THE DAY BEFORE WAS PROCESSED NORMALLY AND HAD YIELDED THE APPROPRIATE FLAGS AND SUBSEQUENT DILUTIONS. NO ERRORS WERE REPORTED BY THE CUSTOMER FOR THE INSTRUMENT. THE CAUSE FOR THE DISCORDANT ESTRADIOL-6 III RESULT IS UNKNOWN. 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 NEAT RESULT FOR ESTRADIOL-6 III DID NOT MATCH THE 1:5 AND THE 1:10 DILUTED RESULTS. THE NEAT RESULT WAS REPORTED TO THE REFERRING CLINIC. THE REPORT WAS THEN AMENDED AND THE 1:10 DILUTION RESULT WAS RELEASED. 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 131

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR