Insulin pump was received with a cracked battery tube threads and a cracked case corner of the belt clip rails near the battery compartment. Pump was received with a missing retainer, missing reservoir tube o-ring and broken reservoir tube lip. The test reservoir does not lock in place and unable to perform the displacement test due to missing retainer, missing reservoir tube o-ring and broken reservoir tube lip. 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. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
Information received by medtronic indicated that the insulin pump? S reservoir lip ring came off. Customer stated that little plastic ring normally connected to pump and on infusion set line and not connected to pump anymore. Customer states also had crack on the back of the pump and was told it was okay. Customer stated that reservoir was 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