Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned. No conclusion can be drawn at this time. We therefore consider this report complete to the best of our knowledge. The insulin pump involved in this event is the 640g 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.
Patient Sequence No: 1, Text Type: N, H10
Information indicated by medtronic that the insulin pump received numerous of times power error detected alarm. Customer stated that the sometimes he got it fr several times a day and he had to reset the insulin pump and the load the reservoir again. No harm requiring medical intervention was reported. The insulin pump will not be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5