BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2200348 · Received August 11, 2011

    Report

    Report Number
    2954323-2011-04155
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 28, 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 METER WAS RETURNED AND INVESTIGATED. CONTROL SOLUTION TESTING WAS PERFORMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. NO NEW ISSUES WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS UNABLE TO CHECK HER BLOOD GLUCOSE LEVEL BECAUSE HER ADC BLOOD GLUCOSE METER DOES NOT START AFTER SAMPLE APPLIED. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING DIZZINESS, SHAKINESS, AND NAUSEOUS. CUSTOMER WENT TO THE EMERGENCY ROOM AND WHEN SHE ARRIVED IN THE FACILITY, SHE LOST CONSCIOUSNESS. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA. CUSTOMER WAS GIVEN AN INTRAVENOUS INFUSION OF UNKNOWN TYPE. CUSTOMER SELF-TREATED WITH INSULIN AND BY DRINKING WATER. 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 093229

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R