BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2152813 · Received July 7, 2011

    Report

    Report Number
    2954323-2011-03785
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 17, 2011
    Report Date
    July 6, 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 DATE OF MANUFACTURE IS UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    SOCIAL WORKER REPORTED THAT THE CUSTOMER WAS NOT ABLE TO TEST HER BLOOD GLUCOSE LEVEL BECAUSE HER ADC BLOOD GLUCOSE MONITOR WAS NOT WORKING PROPERLY. THE CALLER FURTHER REPORTED THAT THE CUSTOMER SUBSEQUENTLY EXPERIENCED LIGHTHEADEDNESS, WEAKNESS, AND VERY PALE. PARAMEDICS WERE CALLED AND THE CUSTOMER WAS TRANSPORTED TO THE HOSPITAL. THE CALLER WAS NOT SURE WHAT WAS THE DIAGNOSIS AND TREATMENT PROVIDED; HOWEVER, THE TREATMENT GIVEN WAS A CHANGE TO THE CUSTOMER'S NORMAL MEDICATION. 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 Other