BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1060761 · Received June 12, 2008

    Report

    Report Number
    2954323-2008-02091
    Event Type
    Malfunction
    Date Received
    June 12, 2008
    Date of Event
    May 13, 2008
    Report Date
    June 12, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S METER HAS BEEN REQUESTED BACK FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING A LOW READING OF 20 MG/DL ON THEIR PRECISION XTRA OPTIUM BLOOD GLUCOSE MONITOR. THE REFERENCE READING OF 130 MG/DL WAS RECEIVED ON THE LAB'S METER WITHIN 10 MINUTES. THE ADC TEST SITE WAS THE FINGER. THE RESULTS PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE LIMITED UK NI 42041

    Patients

    Seq Age Sex Outcome Treatment
    1 NI