BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1151019 · Received August 29, 2008

    Report

    Report Number
    2954323-2008-02471
    Event Type
    Malfunction
    Date Received
    August 29, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC. USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER RETURNED METER. THE COMPLAINT WAS NOT CONFIRMED AND NO NEW ISSUES WERE OBSERVED. ALL RESULTS WERE WITHIN RANGE SPECIFICATION, THE STANDARD DEVIATION WAS WITHIN SPECIFICATION AND NO ERRORS WERE OBSERVED DURING CONTROL SOLUTION TESTING.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED OBTAINING THE READINGS OF 290 MG/DL AND 360 MG/DL ON THEIR BLOOD GLUCOSE METER AND COMPARING TO LAB RESULTS OF 163 MG/DL AND 132 MG/DL. THE TESTS WERE REPORTEDLY PERFORMED WITHIN TEN MINS. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO THE "C" ZONE. THE "C" ZONE RESULT SHOWS 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. USA NI 42918

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Disability