BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1012325 · Received February 11, 2008

    Report

    Report Number
    2954323-2008-01042
    Event Type
    Injury
    Date Received
    February 11, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    LFR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION AND A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A BATTERY ISSUE WITH HIS FREESTYLE BLOOD GLUCOSE METER AND IT WOULD NOT TURN ON PREVENTING HIM FROM TESTING. AS A RESULT, THE CUSTOMER STATED HE EXPERIENCED SYMPTOMS OF STOMACH PAIN, HEADACHE, DIZZINESS AND IRRITABILITY. HE ALSO STATES HE "ALMOST LOST CONSCIOUSNESS BUT NOT FULLY". HE REPORTS BEING SEEN AT A LOCAL HEALTH CARE FACILITY, WAS DIAGNOSED WITH HYPERGLYCEMIA AND WAS ADMINISTERED A GLUCOSE DRINK "LIKE ORANGE JUICE" WHICH IS INCONSISTENT WITH HIS REPORTED DIAGNOSIS AND WAS TREATED WITH IV FLUIDS, BUT DOES NOT KNOW WHAT MEDICATION WAS GIVEN WITH THE IV. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    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 0713713

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other