BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1932393 · Received December 17, 2010

    Report

    Report Number
    2954323-2010-01697
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 22, 2010
    Report Date
    February 17, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1003304) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED. 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.

    Description of Event or Problem · 1

    THE CALLER REPORTED THE CUSTOMER RECEIVED A READING OF 331 MG/DL ON HER FREESTYLE FREEDOM LITE BLOOD GLUCOSE METER, AND THOUGHT THE READING WAS HIGHER THAN SHE FELT. THE CALLER ADDITIONALLY REPORTED THE CUSTOMER OBTAINED HIGH READINGS ALL DAY LONG AND SELF-ADMINISTERED INSULIN. IT WAS FURTHER REPORTED THE CUSTOMER SUBSEQUENTLY LOST CONSCIOUSNESS. THE CUSTOMER WAS TAKEN TO A HOSPITAL BY HER FAMILY WHERE SHE WAS REPORTEDLY DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH AN INTRAVENOUS MEDICATION, "SALT WATER" AND GLUCOSE. A READING OF 22 MG/DL WAS REPORTEDLY OBTAINED ON AN UNKNOWN DEVICE AT AN UNSPECIFIED TIME. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1003304

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R