BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 409618 · Received August 12, 2002

    Report

    Report Number
    2954323-2002-00069
    Event Type
    Injury
    Date Received
    August 12, 2002
    Date of Event
    July 22, 2002
    Report Date
    August 12, 2002
    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

    CUSTOMER CALLED TO REPORT HIGH READINGS CUSTOMER RECEIVED READINGS OF 212, 160, 112, AND 170 WHICH DID NOT REFLECT THE WAY CUSTOMER FELT. READINGS WERE TAKEN WITHIN A SPAN OF ONE AND ONE HALF HOURS. THE PERIOD OF TIME BETWEEN EACH TEST WAS NOT CAPTURED BY THE CUSTOMER. THE CUSTOMER BECAME UNCONSCIOUS, AND PARAMEDICS WERE CALLED. THE PARAMEDICS RECEIVED A READING OF 26 ON A METER OF UNK TYPE. CUSTOMER WAS TRANSPORTED TO THE HOSP, TREATED WITH GLUCOSE, AND RELEASED.

    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