BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1040450 · Received May 8, 2008

    Report

    Report Number
    2954323-2008-01752
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    April 10, 2008
    Report Date
    May 8, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC.
    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. AN INVESTIGATION IS IN PROCESS. A FINAL REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. PLEASE NOTE: THE TEST STRIPS REPORTED BY THE CUSTOMER EXPIRED IN 2007.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT SOMETIME DURING THE MIDDLE OF MONTH THEIR FREESTYLE FLASH BLOOD GLUCOSE MONITOR WOULD NOT POWER ON PROPERLY, AND AS A RESULT THEY COULD NOT OBTAIN A GLUCOSE READING. THEY REPORTED FEELING SHAKY AND NERVOUS, AND GOING TO A LOCAL HEALTH CARE FACILITY. WHILE AT THE HOSPITAL, THE CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND DIABETIC KETOACIDOSIS. ALTHOUGH INCONSISTENT WITH REPORTED DIAGNOSIS, THE CUSTOMER REPORTED BEING TREATED WITH CRACKERS AND CANDY. 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 FLASH BLOOD GLUCOSE MONITORING SYSTEM LFR ABBOTT DIABETES CARE INC. NA 0527726

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization