BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1022579 · Received April 1, 2008

    Report

    Report Number
    2954323-2008-01258
    Event Type
    Injury
    Date Received
    April 1, 2008
    Date of Event
    March 3, 2008
    Report Date
    April 1, 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 INACCURATE HIGH GLUCOSE READING FROM THEIR PRECISION XTRA METER. CUSTOMER REPORTED EXPERIENCING SYMPTOMS OF "LOW BLOOD SUGAR" AND ONE EPISODE OF LOST OF CONSCIOUSNESS. CUSTOMER REPORTED GOING TO HOSPITAL WHERE SHE REPORTS BEING DIAGNOSED WITH SEVERE HYPOGLYCEMIA AND TREATED WITH GLUCOSE GEL, D50 AND D10 IV SOLUTION AND FOOD.

    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 42680

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R