(b)(4). Unit p-cap / reservoir locked properly in place. Unit received with cracked lcd window. Unit received with critical pump error due to moisture damage to force sensor. Unit received with corroded electronic assemblies, corroded battery tube, and corroded motor home switch. Unit unable to perform displacement test, rewind, prime/seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test due to critical pump error (open book image) alarm. 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 received by medtronic indicated that the insulin pump? S crack was seen on display. Customer stated that reservoir able to lock in place when insert into pump. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5