SFDA Alerts about Defective Insulin Pumps for Treatment of High Blood Sugar (Diabetes)

SFDA alerted the users of ‘Animas Vibe’ Insulin Pump, produced by Animas Corporation, and used for continuous injection of insulin ‘under the skin’ for treatment of high blood sugar, as the pump may cause loss of air evacuation alert, blockage  of pumping alert and pump inability to recognize insulin pack.

In a statement, SFDA referred to the model numbers of the affected insulin pumps as follows:

100515-63, 100510-63, 100514-63, 100512-63, 100511-63, 101200-03, 100201-03, 101202-03, 101204-03, 101205-03, 101200-53, 101202-53, 101205-53, 101200-02, 101200-57, 101201-57, 101202-57, 101204-57, 101205-57, 101200-63, 101201-63, 101202-63, 101204-63, 101205-63, 101206-63.

SFDA advised patients to stop using the affected pump models, pointing out that such pumps  are not licensed by SFDA and not released by the points of entry and that the user may have obtained them from other sources. SFDA called people to report about medical devices and products problems through the national center for medical devices report website: http://ncmdr.sfda.gov.sa

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