BEUDAMED
    FDA Adverse Event Other Summary report: N

    ARCHITECT ESTRADIOL REAGENT

    MDR report key: 245552 · Received October 19, 1999

    Report

    Report Number
    1415939-1999-00009
    Event Type
    Other
    Date Received
    October 19, 1999
    Date of Event
    September 19, 1999
    Report Date
    October 18, 1999
    Manufacturer
    ABBOTT LABORATORIES
    Product Code
    CHP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON OR AROUND 09/19/1999, AN ARCHITECT ESTRADIOL RESULT HAD BEEN REPORTED WHICH UNDERESTIMATED THE LEVEL OF ESTRADIOL. THE PT WAS HOSPITALIZED FOR OVARY HYPERSTIMULATION AND AN OVUM ASPIRATION WAS PERFORMED. FURTHER INFO HAS BEEN REQUESTED, BUT HAS NOT BEEN RECEIVED. NO REPORT OF SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARCHITECT ESTRADIOL REAGENT CMIA FOR QUANTITATIVE DETECTION OF ESTRADIOL CHP ABBOTT LABORATORIES NI 49994M100

    Patients

    Seq Age Sex Outcome Treatment
    1 NO INFO ARCHITECT ESTRADIOL REAGENT, LOT NUMBER 54865M100.| ARCHITECT ESTRADIOL REAGENT, LOT NUMBER 54859M100,