BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 1604782 · Received February 18, 2010

    Report

    Report Number
    2954323-2010-00177
    Event Type
    Injury
    Date Received
    February 18, 2010
    Date of Event
    January 26, 2010
    Report Date
    February 18, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE METER ((B) (4)) AND TEST STRIPS (LOT # 0925934) WERE RETURNED FOR AN INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. A READING OF 180 MG/DL WAS FOUND IN THE METER'S MEMORY LOG ON (B) (6) 2010 AT 5:56 P. M. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER'S SON REPORTED THE CUSTOMER RECEIVED A READING OF 181 MG/DL ON HER BLOOD GLUCOSE METER ON (B) (6) 2010 AT APPROXIMATELY 4:45 P. M. THE CUSTOMER'S SON ADDITIONALLY REPORTED THE CUSTOMER EXPERIENCED SYMPTOMS OF PROFUSE SWEATINESS, INCOHERENCE, STIFFNESS AND DRY MOUTH. THE CUSTOMER REPORTEDLY TOOK INSULIN. THE PARAMEDICS WERE CALLED AND A READING OF 42 MG/DL WAS REPORTEDLY OBTAINED ON A HEALTH CARE PROVIDER METER. IT WAS ALSO REPORTED THAT AN INTRAVENOUS "SUGAR WATER" MEDICATION WAS ADMINISTERED TO THE CUSTOMER. 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 0925934

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention