BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2141737 · Received June 27, 2011

    Report

    Report Number
    2954323-2011-03682
    Event Type
    Injury
    Date Received
    June 27, 2011
    Date of Event
    June 6, 2011
    Report Date
    September 22, 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 PRODUCTS HAVE BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1024207) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    ON (B)(6), 2011 A CUSTOMER'S DAUGHTER-IN-LAW REPORTED THE CUSTOMER WAS RECEIVING HIGHER THAN FEELS READINGS USING HIS FREESTYLE FREEDOM METER. NO METER READINGS WERE PROVIDED AS THE DAUGHTER-IN-LAW STATED THAT THE CUSTOMER "DOES NOT REMEMBER THE READING TAKEN IN THE METER." THE DAUGHTER-IN LAW REPORTED "ABOUT A MONTH AGO" AT 4:00 AM, THE CUSTOMER WAS SLEEPING WHEN HE STARTED SWEATING AND LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED AND ADMINISTERED ORAL GLUCOSE TO THE CUSTOMER AT HIS HOME. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY. NO SELF-TREATMENT WAS REPORTED. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW 1024207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R