BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 3211506 · Received July 8, 2013

    Report

    Report Number
    2954323-2013-00364
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    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. THE ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER'S WIFE REPORTED THAT APPROXIMATELY 2-3 WEEKS PRIOR TO CALLING ON (B)(6), 2013 CUSTOMER ATTEMPTED TO PERFORM A TEST USING HIS ADC BLOOD GLUCOSE METER, BUT COULD NOT READ THE RESULT DUE TO FADING SEGMENTS ON THE DISPLAY SCREEN. DUE TO THIS HE WAS NOT ABLE TO TAKE HIS INSULIN PROPERLY. LATER IN THE DAY HE WAS RIDING HIS HORSE AND BEGAN TO EXPERIENCE "LIGHTHEADEDNESS", WAS "SWEATY" AND SUBSEQUENTLY LOST CONSCIOUSNESS, CAUSING HIM TO FALL OFF THE HORSE AND RESULTING IN HIS HEAD HITTING THE GROUND. LATER IN THE DAY, CUSTOMER SELF-PRESENTED TO A LOCAL HEALTHCARE FACILITY WHERE A BLOOD GLUCOSE TEST WAS PERFORMED (UNKNOWN RESULT), A DIAGNOSIS OF HYPERGLYCEMIA WAS GIVEN AND AN INTRAVENOUS INFUSION OF UNKNOWN TYPE WAS ADMINISTERED WITH INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311213 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Hospitalization| O| R