BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA / OPTIUM

    MDR report key: 1011211 · Received May 11, 2007

    Report

    Report Number
    2954323-2007-07694
    Event Type
    Malfunction
    Date Received
    May 11, 2007
    Date of Event
    April 13, 2007
    Report Date
    May 11, 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 PRODUCT HAS BEEN RETURNED AND UPON INVESTIGATION, THE COMPLAINT COULD NOT BE REPRODUCED. HOWEVER, VALID BLOOD GLUCOSE TEST RESULTS OBTAINED FROM THE SAME ADC METER, PERFORMED IN ACCORDANCE TO INSTRUCTIONS FOR USE AND TAKEN WITHIN TEN MINUTES WHICH WHEN PLOTTED ON A PARKES ERROR GRID OR LEROUX NEONATAL GRID, USING THE MEAN OF THE SEQUENTIAL VALUES AS A REFERENCE, FALL INTO THE C ZONE ARE CONSIDERED CLINICALLY SIGNIFICANT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF IMPRECISE SEQUENTIAL READINGS ON THEIR PRECISION XTRA/OPTIUM METER. READINGS OF 14, 5.4, 25.5 AND 7.8 MMOL/L WERE OBTAINED ON THE CUSTOMER'S METER WITHIN A TEN MINUTE TIMEFRAME. EACH OF THE READINGS WERE PLOTTED AGAINST THE AVERAGE ON A PARKES ERROR GRID. THE RESULTS FELL IN THE 'A', 'B' AND 'C' ZONES. THE 'C' ZONE RESULT IS CONSIDERED CLINICALLY SIGNIFICANT. THE CUSTOMER EXPERIENCED SYMPTOMS OF SWEATING, AND FEELING LIGHT HEADED.. 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 NA 41570

    Patients

    Seq Age Sex Outcome Treatment
    1 NI