BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1002479 · Received February 22, 2008

    Report

    Report Number
    2954323-2008-00875
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 25, 2008
    Report Date
    February 22, 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'S SON REPORTED CUSTOMER RECEIVED INACCURATE HIGH GLUCOSE READING (319 MG/DL) FROM THEIR FREESTYLE FLASH METER. CUSTOMER'S SON REPORTED CUSTOMER ACTUAL GLUCOSE LEVEL WAS 37 MG/DL FROM AN UNK METER. THE CUSTOMER WENT INTO A COMA AND WAS UNRESPONSIVE. PARAMEDICS WERE CALLED AND TREATED CUSTOMER WITH INTRAVENOUS GLUCOSE. CUSTOMER WAS THEN TRANSPORTED TO HOSPITAL WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND WAS TREATED WITH GLUCOSE AND FOOD. 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 0714307

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Hospitalization| R