BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM LITE

    MDR report key: 2242134 · Received September 9, 2011

    Report

    Report Number
    2954323-2011-04429
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 17, 2011
    Report Date
    September 9, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE DID NOT INVOLVE A PRODUCT MALFUNCTION. SINCE THE MEDICAL EVENT WAS RELATED TO A TRAINING ISSUE, NO INVESTIGATION OF THE PRODUCT IS REQUIRED. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    A CUSTOMER CALLED IN REQUESTING TRAINING ON CONTROL SOLUTION TEST AND STATED SHE IS A NEWLY DIAGNOSED DIABETIC, AND MIGHT HAVE HAD A MEDICAL EPISODE BECAUSE SHE DID NOT HAVE THE METER SET UP. THE CUSTOMER REPORTEDLY EXPERIENCED NAUSEA, BLURRED VISION AND WAS SEEN BY A DOCTOR WHO DIAGNOSED HER WITH HYPERGLYCEMIA AND TREATED WITH SALINE SOLUTION VIA INTRAVENOUS INFUSION AND HUMALOG. 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 FREEDOM LITE BLOOD GLUCOSE MONITORING SYSTEM NBW 1011818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention