BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2110773 · Received June 1, 2011

    Report

    Report Number
    2954323-2011-03459
    Event Type
    Injury
    Date Received
    June 1, 2011
    Date of Event
    May 10, 2011
    Report Date
    June 1, 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 ACTUAL DATE WHEN THE MEDICAL EVENT OCCURRED IS UNKNOWN.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HER FREESTYLE LITE BLOOD GLUCOSE METER WOULD NOT TURN ON WHEN THE BUTTON WAS PRESSED OR WITH TEST STRIP INSERTION. SHE FURTHER REPORTED SHE HAD TO GO TO THE FIRE DEPARTMENT TO HAVE HER GLUCOSE CHECKED AND NOTED EXPERIENCING VERTIGO, DIFFICULTY AMBULATING, CONFUSION AND NOTED HER FINGER WAS TINGLING. CUSTOMER ALSO REPORTED A READING OF 39 MG/DL, BUT IT IS UNKNOWN ON WHAT METER THIS READING WAS RECEIVED. PARAMEDICS TREATED CUSTOMER WITH A "GLUCOSE SHOT". 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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention