BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA/OPTIUM

    MDR report key: 1070200 · Received July 3, 2008

    Report

    Report Number
    2954323-2008-02194
    Event Type
    Malfunction
    Date Received
    July 3, 2008
    Date of Event
    June 5, 2008
    Report Date
    July 3, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING. ACCORDING TO THE MEMORY LOG OF THE RETURNED METER, THE VALUES GIVEN BY THE CUSTOMER WERE FOUND IN THE MEMORY LOG IN 2008. NOTE: IT SHOULD BE NOTED THAT THIS METER DOES NOT GIVE A NUMERIC VALUE FOR READINGS LESS THAN 20 MG/DL. A "LO" DISPLAY MESSAGE INDICATES A READING LESS THAN 20 MG/DL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 20 MG/DL AND 180 MG/DL WERE PLOTTED ON A PARKES ERROR GRID. THE RESULTS FELL INTO THE "C" ZONES SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. 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 42604

    Patients

    Seq Age Sex Outcome Treatment
    1 NA