BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LITE

    MDR report key: 2091944 · Received May 18, 2011

    Report

    Report Number
    2954323-2011-03295
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    April 13, 2011
    Report Date
    August 29, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT SHOULD HAVE BEEN FILED AS A FINAL AS THIS COMPLAINT DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A MISUSE AS EITHER BLOOD, CONTROL SOLUTION OR OTHER FOREIGN MATERIAL HAS GOTTEN INTO THE STRIP PORT, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. NO SUPPLEMENTAL IS REQUIRED.

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING AN ER-3 MESSAGE ON THEIR FREESTYLE LITE METER AND AS A RESULT OF BEING UNABLE TO TEST, SHE EXPERIENCED LIGHTHEADEDNESS, WEAKNESS, BACKACHE AND SUBSEQUENTLY LOST CONSCIOUSNESS. THE CUSTOMER WAS REPORTEDLY SEEN AT A HEALTH CARE FACILITY WHERE SHE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH "POTASSIUM PILLS, IV, OXYGEN. " IN ADDITION, CHEST AND FINGER X-RAYS WERE PERFORMED AND CUSTOMER ALSO SELF-TREATED WITH GLIPIZIDE 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 1102603

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R