BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 ESTRADIOL

    MDR report key: 1692192 · Received May 12, 2010

    Report

    Report Number
    2017183-2010-00022
    Event Type
    Other
    Date Received
    May 12, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 16, 2010
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    K932926
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE SYSTEM DATA INDICATE THAT THERE ARE NO KNOWN SYSTEM CAUSES WHICH MAY HAVE CONTRIBUTED TO THE INITIAL DISCORDANT LOWER IMMULITE 2000 ESTRADIOL TEST RESULT. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    A DISCORDANT LOW IMMULITE 2000 ESTRADIOL ASSAY RESULT WAS OBTAINED ON A PT SAMPLE AND REPORTED. THE IVF PT SAMPLE WAS EXPECTED TO BE ELEVATED AND WAS INITIALLY RUN AS A TIMES 3X DILUTION. TWO DAYS LATER, THE PHYSICIAN CONTACTED THE CUSTOMER A HORMONE STIMULATION HAD BEEN UNDULY INCREASED. THERE WAS NO REPORT OF PT HARM OR ADVERSE HEALTH CONSEQUENCES DUE TO THE DISCORDANT ESTRADIOL TEST RESULT AND INCREASED STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ESTRADIOL ESTRADIOL IMMUNOASSAY CHP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 271

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK