BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2192144 · Received August 4, 2011

    Report

    Report Number
    2954323-2011-04110
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 23, 2011
    Report Date
    September 15, 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 AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    CUSTOMER'S MOTHER REPORTED THAT THE CUSTOMER RECEIVED A READING OF 117 MG/DL ON HER ADC BLOOD GLUCOSE METER. THE CALLER FURTHER REPORTED THAT THE CUSTOMER SUBSEQUENTLY EXPERIENCING COGNITIVE ISSUES, SPEECH PROBLEM, SHAKINESS, "UNSTABLE", CLAMMY, SEIZING, AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND RESPONDED. PARAMEDICS TESTED THE CUSTOMER'S BLOOD GLUCOSE LEVEL WITH THEIR METER AND RECEIVED A READING OF 23 MG/DL. CUSTOMER WAS TREATED WITH GLUCOSE INJECTION AND WAS TRANSPORTED TO THE HOSPITAL. CUSTOMER WAS DIAGNOSED BY THE DOCTOR OF HYPOGLYCEMIA AND WAS GIVEN ANOTHER GLUCOSE INJECTION. CUSTOMER SELF-TREATED WITH GLUCOSE TABS AND JUICE. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1167454

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R