BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION XTRA /OPTIUM

    MDR report key: 1061093 · Received June 13, 2008

    Report

    Report Number
    2954323-2008-02096
    Event Type
    Malfunction
    Date Received
    June 13, 2008
    Date of Event
    May 16, 2008
    Report Date
    June 13, 2008
    Manufacturer
    ABBOTT DIABETES CARE LIMITED UK
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED. 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. THE READINGS WERE FOUND IN THE METER LOG IN 2008 WITHIN THE 10 MINUTE TIMEFRAME: TIME(H) 23:10 READING (MG/DL) 27. TIME(H) 23:13 READING (MG/DL): 114.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING IMPRECISE READINGS ON THEIR PRECISION XTRA BLOOD GLUCOSE MONITORING SYSTEM. CUSTOMER REPORTED RECEIVING READINGS OF 27 MG/DL AND 114 MG/DL WITHIN 10 MINUTES. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON THE PARKES ERROR GRID 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 MONITORING SYSTEM NBW ABBOTT DIABETES CARE LIMITED UK NI 42529

    Patients

    Seq Age Sex Outcome Treatment
    1 NI