"SFDA" alerted to presence of defect in insulin pump settings and calls for those affected to be replaced for free
2015-05-26
SFDA alerted consumers and health practitioners to the possibility of lost time and date settings after changing the battery of your (Accu-Chek Spirit Combo), manufactured by Roche Diabats Care Co., This may cause to give the patient insulin doses in wrong times. The Commission stated that this problem occurs when device capacitor failed to work properly, because of an electric leakage.
SFDA recommended to Consumers to make sure to set the time and date settings correctly after changing the battery, and for those who have affected alarm device, to communicate with the local distributor (Roche care for diabetes on the toll-free number - 8002443210) to coordinate access to a free alternative device. SFDA called everyone to report on the problems related to medical devices and products through the website of the National Center for communications devices and medical products: http://ncmdr.sfda.gov.sa