BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2162783 · Received July 15, 2011

    Report

    Report Number
    2954323-2011-03853
    Event Type
    Injury
    Date Received
    July 15, 2011
    Date of Event
    June 27, 2011
    Report Date
    July 12, 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. THE DATE OF EVENT IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS CHANGING THE BATTERIES OF HER ADC BLOOD GLUCOSE METER EVERY COUPLE OF DAYS AND THERE WERE TIMES THAT SHE WAS UNABLE TO USE THE METER. AS A RESULT, SHE MAY HAVE ADMINISTERED INCORRECT AMOUNT OF INSULIN DURING THESE TIMES. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCED INTERMITTENT LOW AND HIGH BLOOD SUGAR SYMPTOMS SUCH AS DIZZINESS, BURNING IN LEGS, NEUROPATHY IN HANDS AND FEET, DUPUYTREN'S CONTRACTURE IN HANDS, HEART PALPITATIONS, SWEATING, SEVERE COGNITIVE PROBLEMS, AND SEIZURE. CUSTOMER WAS SEEN BY THE DOCTOR AND WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. SHE WAS TREATED WITH "GLUCO SOMETHING" AS THE CUSTOMER DOES NOT RECALL THE EXACT NAME. CUSTOMER SELF-TREATED WITH GLUCOSE AND BY EATING. THESE EVENTS CHANGED THE NORMAL MEDICATIONS OF THE CUSTOMER. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other