BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1161448 · Received September 10, 2008

    Report

    Report Number
    2954323-2008-02527
    Event Type
    Malfunction
    Date Received
    September 10, 2008
    Date of Event
    August 12, 2008
    Report Date
    September 10, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC, USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 RECEIVING IMPRECISE READINGS ON THEIR BLOOD GLUCOSE METER WITHIN 10 MINUTES. RESULTS OF 1.7 MMOL/L AND 15.1 MMOL/L WERE PLOTTED ON A PARKES ERROR GRID, AND FELL INTO THE "C" ZONE 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC, USA NI 80473

    Patients

    Seq Age Sex Outcome Treatment
    1 NI