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. (b)(4). 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
It was reported via phone that the retainer ring that holds the reservoir has loosened. Customer's blood glucose was unknown at the time of the incident. Customer was advised the insulin pump will be replaced and agreed to return the device for analysis.
Patient Sequence No: 1, Text Type: D, B5