Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time veo insulin infusion pump, which is not marketed in the united states.However, the device is similar to the paradigm real-time insulin infusion pump, which is marketed in the united states.
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The pump passed the displacement test.However, the pump alarmed during the basic occlusion test due to a slightly loose drive support disk.The pump also had a missing end cap sticker, minor scratches on the lcd window, a broken belt clip slot and broken battery tube threads.
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