BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 569018 · Received January 31, 2005

    Report

    Report Number
    2954323-2004-00543
    Event Type
    Injury
    Date Received
    January 31, 2005
    Report Date
    January 31, 2005
    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

    A COMPLAINT OF HIGH READINGS WAS RECEIVED ON A CUSTOMER'S FREESTYLE METER. THE CUSTOMER OBTAINED READINGS OF 191, 144, 163, 130, 196 AND 162 MG/DL. THE CUSTOMER SAYS THE HIGH READINGS HAVE OFTEN LED TO THE ADMINISTRATION OF TOO HIGH A DOSE OF INSULIN WHICH RESULTED IN A HYPOGLYCEMIC REACTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention