BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 3180865 · Received June 20, 2013

    Report

    Report Number
    2954323-2013-00346
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 28, 2013
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE COMPLAINT INVOLVED A DELIVERY ISSUE; HENCE NO PRODUCT INVESTIGATION WILL BE UNDERTAKEN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED BEING UNABLE TO TEST DUE TO NOT RECEIVING A REPLACEMENT METER AND HAVING A CAR ACCIDENT WHILE DRIVING (DUE TO A HIGH BLOOD GLUCOSE). CUSTOMER STATED THAT PARAMEDICS ARRIVED, OBTAINED A READING OF 559 MG/DL ON UNKNOWN BRAND HCP METER, CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN "TYPE F". CUSTOMER WAS ALSO SEEN BY A DOCTOR AND RECEIVED INSULIN "FOR 3 HOURS" AND WAS ADVISED TO KEEP "TAKING THE SAME PILLS". 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
    279733 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention