BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2500 ESTRADIOL

    MDR report key: 1781412 · Received July 28, 2010

    Report

    Report Number
    2017183-2010-00034
    Event Type
    Other
    Date Received
    July 28, 2010
    Date of Event
    June 25, 2010
    Report Date
    July 1, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    K932926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A SIEMENS HEALTHCARE FIELD SERVICE ENGINEER (FSE) WAS SENT TO THE CUSTOMER SITE FOR SYSTEM EVAL. ANALYSIS OF THE SYSTEM BY THE FSE INDICATES THAT THE CAUSE FOR THE DISCORDANT HIGH ESTRADIOL RESULT IS UNK. THE FSE NOTED INCUBATORS JAM ON THE ERROR LOG AND REPLACED THE REAGENT AND SAMPLE MANIFOLDS, HOWEVER THE SERVICE ACTION WAS CONSIDERED UNRELATED TO THE CAUSE OF THE DISCORDANT RESULT. SAMPLE HANDLING IS SUSPECT. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    A DISCORDANT HIGH IMMULITE 2500 ESTRADIOL ASSAY RESULT WAS OBTAINED ON INITIAL AND REPEAT TESTING WHEN COMPARED TO THE PT'S CLINICAL PICTURE, PREVIOUS TEST RESULT, AND ANOTHER ESTRADIOL TEST METHOD. THE PT'S ESTROGEN DOSE WAS STOPPED BASED UPON THE DISCORDANT HIGH ESTRADIOL RESULTS. THERE WAS NO REPORT OF PT HARM OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2500 ESTRADIOL ESTRADIOL IMMUNOASSAY CHP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 202

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR