BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2041927 · Received April 6, 2011

    Report

    Report Number
    2954323-2011-02826
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 26, 2011
    Report Date
    July 20, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED FOR INVESTIGATION. AS OF THIS DATE, NO PRODUCT HAS BEEN RETURNED. RETAIN TESTING IS REQUIRED FOR THE TEST STRIPS ASSOCIATED WITH THE COMPLAINT, HOWEVER, THE TEST STRIPS ARE EXPIRED. A DEVICE HISTORY REVIEW (DHR) OF THE TEST STRIPS WAS PERFORMED. THE DHR FOR TEST STRIPS LOT NUMBER 0606647 INDICATED THE TEST STRIPS WERE PERFORMING WITHIN ITS PERFORMANCE CLAIMS AND MET THE MANUFACTURER'S QUALITY SPECIFICATIONS PRIOR TO THEIR RELEASE. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. NOTE: REPORTED TEST STRIP LOT # 0606647 WAS EXPIRED (EXPIRATION: MARCH, 2008).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL FUNCTIONAL TEST RESULTS WERE WITHIN RANGE SPECIFICATION. NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. THE READINGS THE CUSTOMER REPORTED WERE FOUND IN METER MEMORY.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED SHE DROPPED HER FREESTYLE FREEDOM BLOOD GLUCOSE METER A FEW TIMES AND ON (B)(6) 2011 SHE WAS GETTING READY FOR WORK AND FELT DIZZY, AND THEN OBTAINED A READING OF 10.4 MMOL/L AT 7 AM, BUT CONTINUED TO EXPERIENCE DIZZINESS. THE CUSTOMER WAS REPORTEDLY TAKEN TO A HOSPITAL LATER THAT MORNING BY HER HUSBAND AND WHEN AT THE HOSPITAL, SHE COMPARED THE READING OF 10.4 MMOL/L SHE RECEIVED ON HER ADC METER TO A READING OF 25 MMOL/L OBTAINED ON A HEALTH CARE PROVIDER METER. THE CUSTOMER REPORTED SHE EXPERIENCED DIZZINESS, STOMACH SICKNESS, AND WAS DEHYDRATED. THE CUSTOMER WAS REPORTEDLY DIAGNOSED WITH HYPERGLYCEMIA, AND RECEIVED AN UNSPECIFIED INTRAVENOUS TREATMENT. THE CUSTOMER WAS ADDITIONALLY DIAGNOSED WITH AN EAR INFECTION AND TREATED WITH AN ANTIBIOTIC. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW 0606647

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention