BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1000028 · Received February 7, 2008

    Report

    Report Number
    2954323-2008-00753
    Event Type
    Injury
    Date Received
    February 7, 2008
    Date of Event
    January 9, 2008
    Report Date
    February 7, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS AN INITIAL REPORT. THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF SLURRED SPEECH AND "SHE DIDN'T KNOW WHAT WAS GOING ON AROUND HER". PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO BAY HEALTH HOSPITAL. CUSTOMER REPORTED THAT SHE WAS DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH AN UNK SHOT AND BREAKFAST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 42445

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention