(b)(4). Unit received with missing retainer ring and reservoir tube lip o-ring. Unit received with partially broken off piece at the reservoir tube lip. Unable to perform displacement test and p-cap / reservoir will not lock properly due to missing retainer. Unit received with cracked case (battery tube), cracked case-corner of belt clip rails, and cracked battery tube threads. 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 had a detached retainer ring. The customer stated that the reservoir did lock into place. Troubleshooting was performed for damaged. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5