BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1023403 · Received April 2, 2008

    Report

    Report Number
    2954323-2008-01293
    Event Type
    Injury
    Date Received
    April 2, 2008
    Date of Event
    February 17, 2008
    Report Date
    April 2, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE METER IS RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED RECEIVING A "LO" DISPLAY MESSAGE ON HER PRECISION XTRA/OPTIUM BLOOD GLUCOSE METER AND ALSO EXPERIENCING SYMPTOMS OF DRY MOUTH AND SLEEPINESS. THE PARAMEDICS WERE CALLED, TOOK A BLOOD GLUCOSE READING OF 410 MG/DL, PUT HER ON AN INSULIN INTRAVENOUS DRIP AND TRANSPORTED HER TO A HOSP WHERE SHE STAYED FOR TWO DAYS. AT THE HOSPITAL, SHE ADDITIONALLY REPORTED RECEIVING SOME ORANGE JUICE AND THEN WAS RELEASED TO GO HOME. SHE WAS REPORTEDLY DIAGNOSED WITH DIABETIC KETOACIDOSIS. THE CUSTOMER ALSO REPORTED HAVING SOME HEART PROBLEMS, BUT IT IS UNCLEAR IF THEY WERE RELATED TO THE MEDICAL EVENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVEN.

    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 42445

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Hospitalization| R