BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2143541 · Received June 29, 2011

    Report

    Report Number
    2954323-2011-03708
    Event Type
    Injury
    Date Received
    June 29, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 28, 2011
    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. THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED AN UNSPECIFIED ISSUE WITH HIS FREESTYLE FREEDOM LITE METER "AROUND CHRISTMAS TIME" IN (B)(6) 2010 (DATES NOT SPECIFIED). THE CUSTOMER REPORTED HE EXPERIENCED A FALL, LOSS OF CONSCIOUSNESS, AND A SEIZURE. PARAMEDICS WERE CALLED, AND THE CUSTOMER WAS TRANSPORTED TO A MEDICAL CARE FACILITY, WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA. THE CUSTOMER WAS HOSPITALIZED FOR 2-3 WEEKS, DURING WHICH TIME AN MRI WAS PERFORMED THAT SHOWED "BLEEDING ON THE BRAIN." THE CUSTOMER REPORTED HE HAD SURGERY, BUT DID NOT REPORT OTHER TREATMENT(S). THE CUSTOMER STATED "HIS DOCTOR TOLD HIM THIS EVENT COULD HAVE BEEN DUE TO OUR METER NOT WORKING RIGHT", BUT DID NOT PROVIDE INFORMATION CONCERNING PRODUCT-RELATED ISSUES HE WAS EXPERIENCING WITH HIS ADC METER AT THE TIME OF THE EVENT. TWO ATTEMPTS WERE MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1106901

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R