BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 ESTRADIOL

    MDR report key: 1546245 · Received November 25, 2009

    Report

    Report Number
    2017183-2009-00056
    Event Type
    Other
    Date Received
    November 25, 2009
    Date of Event
    November 7, 2009
    Report Date
    November 11, 2009
    Manufacturer
    SIEMENS HEALTHCARE DIAGNOSTICS INC.
    Product Code
    CHP
    PMA / PMN Number
    K932926
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INSTRUMENT DATA INDICATE THAT THE CAUSE FOR THE DISCORDANT LOWER POSITIVE IMMULITE 2000 ESTRADIOL RESULT IS UNK. THE INSTRUMENT IS PERFORMING WITHIN SPECS. NO FURTHER EVAL OF THE DEVICE IS REQUIRED.

    Description of Event or Problem · 1

    A LOW POSITIVE DISCORDANT IMMULITE 2000 ESTRADIOL ASSAY RESULT WAS OBTAINED ON A PT SAMPLE. THE INITIAL SAMPLE RESULT WAS LOWER THAN EXPECTED AND THE CUSTOMER PERFORMED REPEAT TESTING ON A 1:5 DILUTED SAMPLE. THE 1:5 DILUTED ESTRADIOL RESULT WAS HIGH POSITIVE AND WHAT WAS REPORTED TO THE PHYSICIAN. THE ORIGINAL SAMPLE WAS RE-RUN FOUR DAYS LATER AND RESULTED AS A HIGH POSITIVE RESULT. THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES OR ALTERED PT TREATMENT DUE TO THE DISCORDANT LOW POSITIVE ESTRADIOL ASSAY RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMMULITE 2000 ESTRADIOL ESTRADIOL IMMUNOASSAY CHP SIEMENS HEALTHCARE DIAGNOSTICS INC. NA 266

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR