BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1960696 · Received January 13, 2011

    Report

    Report Number
    2954323-2011-00660
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 16, 2010
    Report Date
    January 13, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT. ADC CUSTOMER SERVICE EDUCATED CUSTOMER ABOUT THE EXPIRATION DATE ON THE VIAL OF STRIPS.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN ASKING ABOUT EXPIRATION DATE ON THE BOTTLE OF STRIPS AND STATED HE WAS UNSURE IF THE METER WAS GIVING HIM ACCURACY. THE CUSTOMER REPORTEDLY EXPERIENCED LIGHTHEADEDNESS AND EMESIS AND WENT TO THE EMERGENCY ROOM, WHERE HE WAS TOLD HIS GLUCOSE LEVEL WAS ABOUT 600MG/DL. THE CUSTOMER FURTHER REPORTED BEING DIAGNOSED WITH HYPERGLYCEMIA AND UNSPECIFIED "THYROID" CONDITION AND TREATED WITH TWO SHOTS OF INSULIN AND SALINE INTRAVENOUS INFUSION TO COUNTERACT THE EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1015708

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention