BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1973411 · Received January 30, 2011

    Report

    Report Number
    2954323-2011-01268
    Event Type
    Injury
    Date Received
    January 30, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 28, 2011
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER'S DAUGHTER REPORTED THE TEST DOESN'T START IN THEIR FREESTYLE FREEDOM LITE METER THAT "POSSIBLY LED TO HER HOSPITALIZATION" AS A RESULT OF BEING UNABLE TO TEST. THE CUSTOMER REPORTEDLY EXPERIENCED "WOOZINESS AND SOME WHEEZING", SELF-PRESENTED AT A HEALTH CARE FACILITY, WAS DIAGNOSED WITH HYPERGLYCEMIA AND "ONSET ASTHMA" AND TREATED WITH INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. 1014646

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R