BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 1951705 · Received January 6, 2011

    Report

    Report Number
    2954323-2011-00093
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 11, 2010
    Report Date
    January 6, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND A SUPPLEMENTAL REPORT WILL BE SENT ONCE NEW INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    AN ADC CUSTOMER REPORTED THAT THEIR FS FREEDOM LITE METER "SHUTS OFF AFTER SAMPLE IS APPLIED" AND A BATTERY ICON WAS OBSERVED ON THE METER SCREEN. CUSTOMER STATED THAT DUE TO THE INABILITY TO TEST WHILE AT HOME ON (B)(6) 2010 HE EXPERIENCED "LOW BLOOD SUGAR" SYMPTOMS. NO SPECIFIC SYMPTOMS WERE REPORTED BY THE CUSTOMER. PARAMEDICS WERE CALLED AND TREATED THE CUSTOMER WITH INTRAVENOUS GLUCOSE ON SCENE AND TRANSPORTED HIM TO A HEALTH CARE FACILITY. CUSTOMER WAS DIAGNOSED WITH HYPOGLYCEMIA AND TREATED WITH METFORMIN AND ORANGE JUICE. NO ADDITIONAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1006131

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention