BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA OPTIUM

    MDR report key: 1060251 · Received June 11, 2008

    Report

    Report Number
    2954323-2008-02087
    Event Type
    Injury
    Date Received
    June 11, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 11, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PROBLEM REPORTED BY CUSTOMER WAS A DELIVERY ISSUE. NO INVESTIGATION IS REQUIRED. IF ANY ADDITIONAL INFO IS RECEIVED, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTED THAT THEY HAD RECEIVED AN ERROR 6 MESSAGE DUE TO THE DATE AND TIME NOT BEING CORRECTLY SET ON THEIR PRECISION XTRA METER. THE CUSTOMER SUBSEQUENTLY REPORTED THEY WERE UNABLE TO TEST DUE TO NOT HAVING RECEIVED A REPLACEMENT METER. CUSTOMER REPORTED LOSING CONSCIOUSNESS TWICE AT HOME. DUE TO EXPERIENCING SYMPTOMS (TYPE OF SYMPTOMS UNKNOWN), CUSTOMER WAS TREATED AT A LOCAL HOSPITAL AND RECEIVED A GLUCOSE READING OF 612 MG/DL. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA. TREATMENT RECEIVED AT HOSPITAL IS NOT KNOWN. CUSTOMER SELF-TREATED WITH GLIPIZIDE TWO DAYS AFTER THE INCIDENT AND DRANK WATER. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE LIMITED UK NI 41763

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Other| R