BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1832787 · Received September 13, 2010

    Report

    Report Number
    2954323-2010-01264
    Event Type
    Injury
    Date Received
    September 13, 2010
    Date of Event
    August 15, 2010
    Report Date
    September 13, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE PRODUCT IS RETURNED AND INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED WHEN SHE ATTEMPTED TO USE HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER, HER TEST DID NOT START AFTER A SAMPLE WAS APPLIED TO THE TEST STRIP. THE CUSTOMER ADDITIONALLY REPORTED SHE EXPERIENCED SYMPTOMS OF BLURRED VISION AND DIZZINESS DUE TO BEING UNABLE TO TEST. THE CUSTOMER WAS REPORTEDLY SEEN BY A DOCTOR WHO DIAGNOSED HER WITH HYPERGLYCEMIA AND TREATED HER WITH AN INTRAVENOUS SOLUTION MEDICATION AND INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1014705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention