BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1211279 · Received October 17, 2008

    Report

    Report Number
    2954323-2008-02732
    Event Type
    Malfunction
    Date Received
    October 17, 2008
    Date of Event
    September 24, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC. USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND AN INVESTIGATION HAS DETERMINED 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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON HER MEDISENSE OPTIUM BLOOD GLUCOSE METER. CUSTOMER REPORTED RECEIVING READINGS OF 450 MG/DL AND 110 MG/DL WITH 10 MINS. ALL TESTS WERE PERFORMED ON THE FINGER. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID 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 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC. USA NI 43511

    Patients

    Seq Age Sex Outcome Treatment
    1 NI