BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE FREEDOM

    MDR report key: 2132743 · Received June 17, 2011

    Report

    Report Number
    2954323-2011-03580
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 8, 2011
    Report Date
    June 16, 2011
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS A FINAL REPORT. THE MEDICAL EVENT WAS RELATED TO A DELIVERY ISSUE, HENCE THERE IS NO INDICATION OF A PRODUCT MALFUNCTION. THEREFORE NO INVESTIGATION OF THE PRODUCT IS REQUIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT HE WAS UNABLE TO CHECK HIS BLOOD GLUCOSE LEVELS BECAUSE OF HIS ADC PRODUCTS WERE DELIVERED TO A WRONG ADDRESS. CUSTOMER FURTHER REPORTED SUBSEQUENTLY EXPERIENCING WEAKNESS AND SHAKINESS. PARAMEDICS CAME AND GAVE HIM A "SHOT" TO LOWER HIS BLOOD SUGAR. NO FURTHER INFORMATION WAS PROVIDED. 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 FREEDOM BLOOD GLUCOSE MONITORING SYSTEM NBW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention