BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE

    MDR report key: 1880718 · Received October 25, 2010

    Report

    Report Number
    2954323-2010-01476
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 23, 2010
    Report Date
    October 22, 2010
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CUSTOMER'S WIFE REPORTED NOT RECEIVING THEIR ORDERED METER ON TIME AND AS A RESULT OF BEING UNABLE TO TEST, THE CUSTOMER EXPERIENCED TREMULOUSNESS, PALENESS AND DIAPHORESIS. THE CUSTOMER REPORTEDLY WENT TO THE ER WHERE HE WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH INSULIN AND METFORMIN. 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 BLOOD GLUCOSE MONITORING SYSTEM NBW

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention