BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA / OPTIUM

    MDR report key: 1012487 · Received March 12, 2008

    Report

    Report Number
    2954323-2008-01047
    Event Type
    Malfunction
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 12, 2008
    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

    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 MONITOR. CUSTOMER REPORTED RECEIVING READINGS OF 20 MG/DL, 220 MG/DL AND 20 MG/DL WITHIN 10 MINUTES. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT 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 42729

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK