BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1010147 · Received March 10, 2008

    Report

    Report Number
    2954323-2008-01025
    Event Type
    Injury
    Date Received
    March 10, 2008
    Date of Event
    February 9, 2008
    Report Date
    March 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 RECEIVING AN INACCURATELY LOW GLUCOSE READING (67 MG/DL) FROM THEIR PRECISION XTRA METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF DIZZINESS, TIREDNESS, SLEEPINESS AND ONE EPISODE OF FALLING. CUSTOMER REPORTED GOING TO HER DOCTOR WHO DIAGNOSED CUSTOMER WITH SEVERE HYPERGLYCEMIA AND TREATED HER WITH GLIPIZIDE AND METFORMIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NA 42081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention