BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1781886 · Received June 29, 2007

    Report

    Report Number
    2954323-2007-11497
    Event Type
    Malfunction
    Date Received
    June 29, 2007
    Date of Event
    May 31, 2007
    Report Date
    June 29, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 RETURNED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT THEY WERE OBTAINING IMPRECISE READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED READINGS TAKEN WITHIN A TEN-MINUTE TIMEFRAME OF 8.1 MMOL/L AND 1.1 MMOL/L AT 6:05 AM. EACH READING WAS PLOTTED AGAINST THE AVERAGE ON A PARKES ERROR GRID. THE RESULTS FELL IN THE 'B' AND 'C' ZONES. THE 'C' ZONE RESULT IS CONSIDERED TO BE CLINICALLY SIGNIFICANT. THE CUSTOMER DID NOT MAKE ANY CHANGES TO THEIR MEDICATION BASED ON THESE READINGS. 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 41718

    Patients

    Seq Age Sex Outcome Treatment
    1 NI