BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2424276 · Received January 20, 2012

    Report

    Report Number
    2954323-2012-05716
    Event Type
    Injury
    Date Received
    January 20, 2012
    Date of Event
    January 2, 2012
    Report Date
    January 20, 2012
    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 AVAILABLE. IT SHOULD BE NOTED THE CUSTOMER HAD EXPIRED TEST STRIPS (LOT # 0820019), EXP. DATE 07/18/2010.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THE TEST DOES NOT START AFTER A SAMPLE IS APPLIED TO THE TEST STRIP USING THEIR ADC METER. AS A RESULT OF THIS ISSUE, THE CUSTOMER REPORTED THAT AT 2:00PM ON (B)(6), 2012 THEY EXPERIENCED SYMPTOMS OF "DIZZY AND WEAK". PARAMEDICS WERE CALLED AND ADMINISTERED INTRAVENOUS GLUCOSE TO THE CUSTOMER. THE CUSTOMER WAS NOT TRANSPORTED TO A HEALTH CARE FACILITY, AND DID NOT ATTEMPT TO SELF-TREAT TO COUNTERACT THE EVENT. THERE IS 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 0820019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention