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Important information on Accu-Chek Spirit Combo insulin pumps

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Roche Diabetes Care has issued a Safety Notice to advise users of the potential for the loss of date and time settings on the Accu-Chek- Spirit Combo insulin pump.Roche Diabetes Care has become aware that in a limited number of cases, patients using the Accu-Chek Spirit Combo insulin pump may experience a loss of the date and time settings. A thorough investigation of the situation revealed that this issue may occur if the pump capacitor fails to function properly due to a leakage. The capacitor provides the necessary voltage to save time and date settings during power interruption, typically during a battery change.Given the rare case that the above mentioned issue occurs, this will result in the pump resetting to the default date and time and requiring the user to set or re-program the correct date and time on the pump. In such cases the user might accidentally overlook the change to the default date and time and confirm the default date and time settings provided by the pump. As a result, a shift of the basal rate time block would occur, which could potentially contribute to hyper- or hypoglycemic events. In users with impaired vision, it may be particularly difficult to detect the date and time loss.Users of the Accu-Chek Spirit Combo insulin pump need to be aware of this issue and ensure time and date is set correctly on their pump after a battery change. Users who experience any failures associated with this issue should contact the Accu-Chek Customer Service Center.

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