BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISON XTRA/OPTIUM

    MDR report key: 1032634 · Received April 21, 2008

    Report

    Report Number
    2954323-2008-01550
    Event Type
    Malfunction
    Date Received
    April 21, 2008
    Date of Event
    March 25, 2008
    Report Date
    April 21, 2008
    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

    THE PRODUCT WAS RETURNED AND THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO NEW ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A HEALTH CARE FACILITY REPORTED THAT THEY OBTAINED HIGH READINGS ON THEIR PRECISION XTRA METER. THE CUSTOMER REPORTED THAT THEY OBTAINED READINGS OF 79 MG/DL AND 152 MG/DL COMPARED TO 40 MG/DL AND 93 MG/DL WITH A LAB WITHIN A 10 MIN TIMESCALE. WHEN PLOTTED ON A PARKES ERROR GRID, ONE OR MORE OF THE RESULTS FELL IN THE 'C' ZONE SHOWING THE DIFFERENCES IN THE VALUES ARE CLINICALLY SIGNIFICANT. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY OR MISTREATMENT ASSOCIATED WITH THIS CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRECISON XTRA/OPTIUM BLOOD GLUCOSE METER NBW ABBOTT DIABETES CARE LIMITED UK NI 80234

    Patients

    Seq Age Sex Outcome Treatment
    1 NI