BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1000071 · Received February 15, 2008

    Report

    Report Number
    2954323-2008-00821
    Event Type
    Injury
    Date Received
    February 15, 2008
    Date of Event
    January 16, 2008
    Report Date
    February 15, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER FINGER WAS BRUISED, PAINFUL AND INFECTED AFTER USING THE FREESTYLE FLASH LANCET DEVICE TO RETRIEVE BLOOD. CUSTOMER REPORTED SEEKING MEDICAL INTERVENTION FROM A DOCTOR WHO TREATED CUSTOMER WITH AN ANTIBIOTIC. CUSTOMER ALSO REPORTED BEING DIAGNOSED WITH DIABETIC KETOACIDOSIS, BUT IT IS UNKNOWN WHEN AND WHERE THE DIAGNOSIS WAS MADE, AND IF THE CUSTOMER WAS TREATED FOR THIS CONDITION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC, USA NA 0605575

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention