BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2202880 · Received August 11, 2011

    Report

    Report Number
    2954323-2011-04170
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 24, 2011
    Report Date
    August 11, 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HER ADC BLOOD GLUCOSE METER DOES NOT START AFTER SAMPLE APPLIED. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING WEAKNESS, CONFUSION, AND FELL 3 TIMES AND HIT HER HEAD AND SHOULDER. PARAMEDICS WERE CALLED AND RESPONDED. PARAMEDICS TESTED THE CUSTOMER'S BLOOD SUGAR LEVEL ON THEIR METER AND RECEIVED A READING OF 43 MG/DL. CUSTOMER WAS TRANSPORTED TO THE HOSPITAL AND WAS SEEN BY THE DOCTOR. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND WAS TREATED WITH GLUCOSE INTRAVENOUSLY. CUSTOMER WAS ALSO GIVEN ACTOPLUS, DIOVAN, ASPIRIN, BYSTOLIC, PRANDIN, SIMVASTATIN, AND METFORMIN. CUSTOMER DENIED SELF-TREATMENT. ON THE NEXT DAY, CUSTOMER'S ADC BLOOD GLUCOSE METER STILL DOES NOT START AFTER SAMPLE APPLIED AND THE CUSTOMER WAS TRANSPORTED BACK TO THE HOSPITAL BY THE PARAMEDICS DUE TO CONFUSION. CUSTOMER RECEIVED AN X-RAY. NO FURTHER INFORMATION WAS 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 1009627

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention