BEUDAMED
    FDA Adverse Event Other Summary report: N

    IMMULITE 2000 ESTRADIOL

    MDR report key: 1400173 · Received May 19, 2009

    Report

    Report Number
    2017183-2009-00024
    Event Type
    Other
    Date Received
    May 19, 2009
    Date of Event
    April 24, 2009
    Report Date
    April 24, 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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF INSTRUMENT AND INSTRUMENT DATA DID NOT INDICATE SYSTEM ERROR. THERE IS NO KNOWN CAUSE FOR THE DISCORDANT ESTRADIOL RESULT. NO FURTHER EVAL OF THE DEVICE IS REQUIRED. THE INSTRUMENT IS PERFORMING WITHIN SPECS.

    Description of Event or Problem · 1

    A DISCORDANT IMMULITE 2000 ESTRADIOL ASSAY RESULT WAS OBTAINED ON A PT SAMPLE. THE SAMPLE INITIAL RESULT WAS LOW POSITIVE AND REPORTED TO THE PHYSICIAN WHO QUESTIONED THE RESULT. SAMPLE WAS DILUTED AND RE-RUN WITH HIGHER POSITIVE RESULT. CUSTOMER DRAWN A NEW PT SAMPLE THE NEXT TWO DAYS AND RUN NEW SAMPLE WITH HIGH RESULT. THE SAMPLE WAS DILUTED AND RE-RUN RESULTED HIGHER POSITIVE RESULT. PT TREATMENT WAS WITHHELD UNTIL RESULT WAS VERIFIED. NO INDICATION OF PT TREATMENT WAS ADMINISTERED DUE TO THE REPORTED INITIAL RESULT. PT TREATMENT WAS NOT ALTERED AND THERE WAS NO REPORT OF ADVERSE HEALTH CONSEQUENCES DUE TO THE LOWER POSITIVE DISCORDANT 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 251

    Patients

    Seq Age Sex Outcome Treatment
    1