BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1802648 · Received September 18, 2007

    Report

    Report Number
    2954323-2007-17437
    Event Type
    Malfunction
    Date Received
    September 18, 2007
    Date of Event
    August 18, 2007
    Report Date
    September 18, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 ERRATIC READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 67 MG/DL, 256 MG/DL, AND 258 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER REPORTED DRINKING A LARGE AMOUNT OF ORANGE JUICE BASED ON READINGS OBTAINED, AND THEN REPORTED EXPERIENCING BLURRED VISION, AND "SMELLING KETONES ON THEIR BREATH". HOWEVER, THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY ASSOCIATED WITH THIS EVENT.

    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