BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2001885 · Received February 25, 2011

    Report

    Report Number
    2954323-2011-01746
    Event Type
    Injury
    Date Received
    February 25, 2011
    Date of Event
    February 10, 2011
    Report Date
    February 25, 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 CUSTOMER'S PRODUCTS HAVE 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 APPROXIMATELY ONE WEEK PRIOR TO CALLING CUSTOMER SERVICE ON (B)(6), 2011 HE RECEIVED A READING OF 175 MG/DL ON HIS FREESTYLE LITE BLOOD GLUCOSE METER. HE FURTHER REPORTED EXPERIENCING TIGHTNESS IN HIS NECK AND SUBSEQUENTLY LOST CONSCIOUSNESS. PARAMEDICS WERE CALLED, INITIATED AN INTRAVENOUS INFUSION OF UNKNOWN TYPE AND TRANSPORTED CUSTOMER TO A LOCAL HEALTHCARE FACILITY. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA. CUSTOMER WAS UNABLE TO STATE WHAT ADDITIONAL TREATMENT MAY HAVE BEEN RENDERED AT THE HOSPITAL. 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 LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1006101

    Patients

    Seq Age Sex Outcome Treatment
    1 Other