BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2177111 · Received July 26, 2011

    Report

    Report Number
    2954323-2011-03954
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 30, 2011
    Report Date
    October 14, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    REQUESTED PRODUCT WAS NOT RECEIVED FOR INVESTIGATION. RETAINED TEST STRIP SAMPLES FROM THE SAME LOT REPORTED BY THE CUSTOMER (1160955) WERE TESTED WITH CONTROL SOLUTION INSTEAD. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED. THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER'S SON REPORTED THAT THE CUSTOMER EXPERIENCED DIZZINESS AND THE CUSTOMER RECEIVED A READING OF 98 MG/DL ON HER ADC BLOOD GLUCOSE METER, WHICH WAS HIGHER THAN SHE FELT. CUSTOMER THEN FELL TO SLEEP, LOST CONSCIOUSNESS, AND BECAME UNRESPONSIVE. PARAMEDICS WERE CALLED AND RESPONDED. CUSTOMER BLOOD GLUCOSE LEVEL WAS TESTED AND RECEIVED A READING OF 51 MG/DL FROM THE PARAMEDICS METER AND 90 MG/DL FROM THE ADC METER. CUSTOMER WAS TREATED WITH GLUCOSE ORALLY THAT LOOKS LIKE "CAKE FROSTING". CUSTOMER WAS TRANSPORTED TO A HEALTH CARE FACILITY. NO DIAGNOSES AND TREATMENT WERE PROVIDED. 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 1160955

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R