BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1800622 · Received September 7, 2007

    Report

    Report Number
    2954323-2007-16679
    Event Type
    Malfunction
    Date Received
    September 7, 2007
    Date of Event
    August 8, 2007
    Report Date
    September 7, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    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 ONCE THE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS WAS RECEIVED ON A CUSTOMER'S PRECISION XTRA METER. THE CUSTOMER OBTAINED READINGS OF "LO" (A "LO" MESSAGE INDICATES A READING LESS THAN 1 MMOL/L) AND 15 MMOL/L WITHIN A TEN MINUTE TIMEFRAME. WHEN PLOTTED AGAINST THE AVERAGE ON A PARKES ERROR GRID, THE RESULTS FALL IN THE 'B' AND 'C' ZONES. THE 'C' ZONE RESULT SHOWS THE DIFFERENCE IN READINGS TO BE CLINICALLY SIGNIFICANT. 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 NBW ABBOTT DIABETES CARE LIMITED UK NI 41370

    Patients

    Seq Age Sex Outcome Treatment
    1 NI