BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1033076 · Received April 22, 2008

    Report

    Report Number
    2954323-2008-01565
    Event Type
    Injury
    Date Received
    April 22, 2008
    Date of Event
    November 9, 2007
    Report Date
    April 22, 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 NOT BEING ABLE TO TEST HER BLOOD GLUCOSE BECAUSE HER METER SHOWS PREVIOUS RESULTS UPON STRIPS INSERTION. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF ITCHINESS, RASH, HEADACHE AND VISION PROBLEM. PARAMEDICS WERE CALLED AND TRANSPORTED CUSTOMER TO PARK PLAZA HOSPITAL WHERE SHE WAS BEING DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND TREATED WITH UNKNOWN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDISENSE OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 42017

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R