BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 448449 · Received March 17, 2003

    Report

    Report Number
    2954323-2003-00029
    Event Type
    Injury
    Date Received
    March 17, 2003
    Date of Event
    February 28, 2003
    Report Date
    March 17, 2003
    Manufacturer
    THERASENSE, INC.
    Product Code
    LFR
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    CUSOTMER TESTED WITH THE FREESTYLE METER AT SCHOOL RECEIVING A READING OF 135 MG/DL. THEY WERE EXPERIENCING SYMPTOMS OF LOW BLOOD GLUCOSE AND THE SCHOOL NURSE ADMINISTERED OJ TO THE CUSTOMER. THEY WERE TAKEN TO THE HOSP WHERE THEIR BLOOD GLUCOSE READING WAS TAKEN AS 32 MG/DL WITH AN UNK METER. THE CUSTOMER WAS TREATED WITH AN IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE BLOOD GLUCOSE MONITORING SYSTEM LFR THERASENSE, INC. NA *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention