BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2182456 · Received July 28, 2011

    Report

    Report Number
    2954323-2011-04021
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    July 8, 2011
    Report Date
    September 15, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS NOT CONFIRMED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INTERMITTENT ISSUE WITH THEIR FREESTYLE FREEDOM LITE METER WHEN THE TEST DOESN'T START UPON SAMPLE APPLICATION AND AS A RESULT OF BEING UNABLE TO TEST ON (B)(6) 2011 THE CUSTOMER FELL ON THE GROUND EXPERIENCING SEIZURE AND BRUISED HER KNEES. THE CUSTOMER DENIED THIRD-PARTY MEDICAL INTERVENTION AND REPORTEDLY SELF-TREATED BY EATING FOOD WITH ORANGE JUICE TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1163947

    Patients

    Seq Age Sex Outcome Treatment
    1 Other