BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2191570 · Received August 4, 2011

    Report

    Report Number
    2954323-2011-04103
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 15, 2011
    Report Date
    August 4, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6), 2011, A CUSTOMER CALLED TO REPORT HIS FREESTYLE FREEDOM LITE METER HAD A BLANK SCREEN. THE CUSTOMER REPORTED AS A RESULT OF NOT BEING ABLE TO TEST DUE TO THE BLANK SCREEN, ON (B)(6), 2011 BETWEEN 12:00PM AND 6:00PM HE EXPERIENCED SYMPTOMS DESCRIBED AS "DIZZY, FATIGUED, LEG PAIN, BLURRED VISION, ITCHING ALL OVER BODY, FREQUENT URINATION." THE CUSTOMER SELF-PRESENTED TO A HEALTH CARE FACILITY AND WAS DIAGNOSED WITH HYPERGLYCEMIA. NO READINGS WERE PROVIDED. THE CUSTOMER REPORTED TREATMENT WITH METFORMIN AND ACTOS, WHICH HE STATED WAS A CHANGE FROM HIS NORMAL MEDICATIONS. NO SELF-TREATMENT WAS REPORTED. THIS IS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1157505

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention