BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1771055 · Received June 19, 2007

    Report

    Report Number
    2954323-2007-10763
    Event Type
    Malfunction
    Date Received
    June 19, 2007
    Date of Event
    May 21, 2007
    Report Date
    June 19, 2007
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S PRODUCT WAS RETURNED AND THE READINGS COMPLAINT WAS NOT CONFIRMED. ALL RESULTS WERE WITHIN RANGE SPECIFICATIONS AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A COMPLAINT OF HIGH READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER. THE CUSTOMER OBTAINED A READING OF 142MG/DL COMPARED TO A LABORATORY READING OF 76MG/DL. THE READINGS WERE TAKEN WITHIN A 10 MINUTE TIMEFRAME. WHEN PLOTTED ON A PARKES ERROR GRID THE RESULTS FALL IN THE 'C' ZONE SHOWING THE DIFFERENCE IN READINGS TO BE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OF MISTREATMENT. THE CUSTOMER'S METER AND TEST STRIPS HAVE BEEN RETURNED; INVESTIGATIONS ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISION XTRA /OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK N/A 41373

    Patients

    Seq Age Sex Outcome Treatment
    1 NI