BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1661326 · Received April 15, 2010

    Report

    Report Number
    2954323-2010-00502
    Event Type
    Injury
    Date Received
    April 15, 2010
    Date of Event
    March 20, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ABBOTT DIABETES CARE, INC. USA
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BOTH METERS AND TEST STRIPS OF LOT # 0922602 WERE RETURNED FOR INVESTIGATION. THE COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN THE RANGE SPECIFICATION DURING CONTROL SOLUTION TESTING. ON METER (B) (4), THE READING OF 180 MG/DL WAS NOT FOUND IN THE MEMORY LOG ON THE DAY OF THE EVENT. ON METER (B) (4), NO READINGS WERE FOUND IN THE MEMORY LOG PRIOR TO INVESTIGATION. THIS IS THE FINAL REPORT. THE MANUFACTURE DATE OF BOTH METERS IS 07-MAR-2008.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED THE CUSTOMER EXPERIENCED A SEIZURE AT 1:30 PM AND THEY WENT TO A HEALTH CARE FACILITY. IT WAS ADDITIONALLY REPORTED THE CUSTOMER COMPARED TWO READINGS THEY RECEIVED AT 1:45 PM ON TWO ADC BLOOD GLUCOSE METERS TO A READING OF 35 MG/DL OBTAINED ON A HEALTH CARE PROVIDER METER AT 1:55 PM. THE REPORTED ADC READINGS WERE: ON METER (B) (4), THE READING WAS 180 MG/DL AND ON METER (B) (4), THE READING WAS 110 MG/DL. BOTH READINGS WERE REPORTEDLY COMPLETED USING TEST STRIPS FROM LOT # 0922602. THE CUSTOMER WAS REPORTEDLY DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH GLUCAGON AND AN INTRAVENOUS MEDICATION (UNKNOWN). THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE, INC. USA NI 0922602

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R