BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2083338 · Received May 10, 2011

    Report

    Report Number
    2954323-2011-03224
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 18, 2011
    Report Date
    May 6, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. CUSTOMER INDICATED SHE HAD DISPOSED OF HER METER AND TEST STRIPS, SO NO PRODUCT WILL BE RETURNED AND HENCE NO FURTHER INVESTIGATION WILL BE UNDERTAKEN. NOTE: THE DATE OF MANUFACTURE IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER'S FAMILY MEMBER REPORTED CUSTOMER CHECKED HER GLUCOSE BEFORE DINNER AND RECEIVED A READING OF 454 MG/DL ON HER FREESTYLE FREEDOM BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN SHE FELT. CALLER FURTHER REPORTED SHE RECHECKED HER GLUCOSE AFTER DINNER AND RECEIVED THE SAME RESULT OF 454 MG/DL. CALLER NOTED CUSTOMER EXPERIENCED ANXIETY FROM NOT KNOWING WHAT HER ACTUAL GLUCOSE RESULT WAS, WHAT TO DO ABOUT THE RESULT OBTAINED AND FATIGUE. CUSTOMER SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY WHERE A READING OF 258 MG/DL WAS RECEIVED AND WAS DIAGNOSED WITH HYPERGLYCEMIA. SHE RECHECKED HER GLUCOSE ON HER METER AGAIN AT THE HOSPITAL AND CONTINUED TO RECEIVE THE RESULT OF 454 MG/DL. CUSTOMER WAS TREATED WITH AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND INSULIN, WHICH WAS A CHANGE TO HER NORMAL MEDICATION REGIMEN. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention