BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1577195 · Received January 13, 2010

    Report

    Report Number
    2954323-2010-00048
    Event Type
    Injury
    Date Received
    January 13, 2010
    Date of Event
    December 18, 2009
    Report Date
    January 13, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER HAS BEEN RETURNED AND INVESTIGATED. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED GETTING A GLUCOSE READING OF 210 MG/DL AT 12:00 PM THAT WAS HIGHER THAN HE FELT AND SELF-MEDICATING WITH 8 UNITS OF HUMALOG. HE REPORTEDLY LOST CONSCIOUSNESS AND COULD NOT BE ROUSED FROM A NAP AT 3:00 PM. HOWEVER, HE FURTHER REPORTED GETTING A READING OF 86 MG/DL AT 3:00 PM PRIOR TO CALLING EMS. THE PARAMEDICS REPORTEDLY TREATED CUSTOMER WITH GLUCAGON. THE CUSTOMER WAS NOT TRANSPORTED TO A LOCAL HEALTH CARE FACILITY AND REPORTEDLY SELF-TREATED WITH ORANGE JUICE. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 0920501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R