BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1213705 · Received October 24, 2008

    Report

    Report Number
    2954323-2008-02772
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    August 15, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. THE FOLLOW-UP REPORT WILL BE SENT WHEN INVESTIGATIONAL RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT AS A RESULT OF BEING UNABLE TO MONITOR HER BLOOD GLUCOSE LEVEL DUE TO RECEIVING AN ERROR MESSAGE ON THEIR FREESTYLE FLASH METER, SHE EXPERIENCED DIZZINESS AND FELL, WHICH RESULTED IN A HIP FRACTURE. SHE REPORTED BEING SEEN AT LOCAL HOSPITAL BY A DOCTOR WHO DIAGNOSED HER WITH HYPERGLYCEMIA, AND TREATED WITH INSULIN. 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 NI 0809636

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R