BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FLASH

    MDR report key: 1171225 · Received September 17, 2008

    Report

    Report Number
    2954323-2008-02572
    Event Type
    Injury
    Date Received
    September 17, 2008
    Date of Event
    August 18, 2008
    Report Date
    September 17, 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 A FINAL REPORT. THE CUSTOMER RETURNED THE METER TO THE CLINIC WHERE HE RECEIVED THE METER TWO YEARS AGO, AND PRODUCT IS NOT EXPECTED TO BE RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT TWO YEARS AGO, THEY RECEIVED A READING OF APPROX 300 MG/DL WHICH WAS HIGHER THAN THEY FELT AND TOOK INSULIN ON A SLIDING SCALE BASED ON THE READING. AS A RESULT, WITHIN THIRTY MINS, THE CUSTOMER EXPERIENCED SYMPTOMS OF HYPOGLYCEMIA AND THE PARAMEDICS WERE CALLED. THE CUSTOMER WAS TREATED WITH GLUCAGON AND TRANSPORTED TO A MEDICAL CENTER WHERE HE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND HAD BLOOD WORK DONE. NO ADD'L TREATMENT WAS REPORTED. 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, USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention