BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 1584387 · Received January 20, 2010

    Report

    Report Number
    MW5014448
    Event Type
    Injury
    Date Received
    January 20, 2010
    Date of Event
    January 7, 2010
    Report Date
    January 20, 2010
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I KEPT RECEIVING UNUSUALLY HIGH READINGS FROM MY FREE STYLE LITE TESTING. I DOUBLED MY DOSE OF METFORMIN AND THEN PASSED OUT FROM MY BLOOD SUGAR DROPPING TOO LOW. DOSE OR AMOUNT: 2; FREQUENCY: DAILY; ROUTE: CUTANEOUS. DATES OF USE: (B) (6) 2009 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: TYPE 2 DIABETES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABBOTT FREE STYLE LITE TEST STRIPS NBW ABBOTT DIABETES CARE INC. ART 10793 0911334

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other