BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDISENSE OPTIUM

    MDR report key: 1181803 · Received September 18, 2008

    Report

    Report Number
    2954323-2008-02579
    Event Type
    Malfunction
    Date Received
    September 18, 2008
    Date of Event
    August 25, 2008
    Report Date
    September 18, 2008
    Manufacturer
    ABBOTT DIABETES CARE INC., USA
    Product Code
    NBW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PROD HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A F/U REPORT WILL BE FILED ONCE INVESTIGATION RESULTS ARE AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED RECEIVING ERRATIC READINGS ON THEIR BLOOD GLUCOSE MONITOR WITHIN 10 MINS. RESULTS OF 72 MG/DL AND 340 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 MEDISENSE OPTIUM BLOOD GLUCOSE MONITORING SYSTEM NBW ABBOTT DIABETES CARE INC., USA NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA