BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 1971206 · Received January 26, 2011

    Report

    Report Number
    2954323-2011-01129
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 23, 2010
    Report Date
    February 23, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER'S METER WAS RETURNED AND INVESTIGATED. POWERED ON METER WITH BUTTON DEPRESSION AND WITH INSERTION OF STRIPS. LOW BATTERY ICON WAS NOT OBSERVED. THE COMPLAINT WAS NOT CONFIRMED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETUNED FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    THE CUSTOMER'S FAMILY MEMBER REPORTED THE CUSTOMER NOTICED A BATTERY ICON MESSAGE ON THE DISPLAY OF HER FREESTYLE LITE BLOOD GLUCOSE METER AND SHE DID NOT REPLACE THE BATTERY SINCE SHE OBSERVED THE ICON/MESSAGE. IT WAS ADDITIONALLY REPORTED THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND PARAMEDICS WERE CALLED. THE CUSTOMER WAS REPORTEDLY TREATED WITH GLUCOSE INTRAVENOUSLY AND TRANSPORTED TO A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPOGLYCEMIA, BUT NO FURTHER MEDICAL INTERVENTION WAS REQUIRED: THE CUSTOMER JUST HAD HER BLOOD GLUCOSE LEVEL CHECKED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1071901

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R