BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2800780 · Received October 23, 2012

    Report

    Report Number
    2954323-2012-06666
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    August 1, 2012
    Report Date
    October 17, 2012
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS HAVE BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER'S SON-IN-LAW REPORTED THAT IN THE BEGINNING OF (B)(6), CUSTOMER RECEIVED A "HIGH READING, ABOVE 350 MG/DL" (ACTUAL READING UNKNOWN), ON HER ADC BLOOD GLUCOSE METER AT 11:00 PM AND SELF-ADMINISTERED HER "NORMAL NOVOLOG INSULIN DOSE" (ACTUAL DOSE IS UNKNOWN). LATER, AT 4:35 AM CUSTOMER WAS FOUND ON HER BEDROOM FLOOR, CRAWLING UNDER THE BED AND MOANING. IT WAS ADDITIONALLY REPORTED HER EYES WOULD NOT OPEN AND SHE WOULD NOT RESPOND. PARAMEDICS WERE CALLED, RECEIVED A READING OF 37 MG/DL ON THEIR METER AND TREATED CUSTOMER ON THE SCENE WITH GLUCOSE VIA INTRAVENOUS INFUSION. CUSTOMER WAS ALSO ENCOURAGED TO EAT SOME FOOD. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other| R