BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1781704 · Received June 26, 2007

    Report

    Report Number
    2954323-2007-11271
    Event Type
    Malfunction
    Date Received
    June 26, 2007
    Date of Event
    May 28, 2007
    Report Date
    June 26, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    LFR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S METER AND TEST STRIPS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW UP REPORT WILL BE SUBMITTED IF THE PRODUCTS ARE RECEIVED.

    Description of Event or Problem · 1

    A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS WAS REPORTED ON A CUSTOMER'S PRECISION XTRA METER. THE CUSTOMER OBTAINED READINGS OF 401, 500 AND 163MG/DL WITHIN A TEN MIN TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID, A RESULT FELL WITHIN THE "C" ZONE WHICH IS CLINICALLY SIGNIFICANT. IT IS TO BE NOTED THAT THE CUSTOMER DID NOT KNOW IF THEY HAD WASHED THEIR HANDS PRIOR TO TESTING. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER LFR ABBOTT DIABETES CARE LIMITED UK NA 41665

    Patients

    Seq Age Sex Outcome Treatment
    1 NI