(b)(4). Unit received with missing retainer ring and reservoir tube lip o-ring. Unable to perform displacement test and p-cap / reservoir will not lock properly due to missing retainer. Unit passed selftest, sleep current measurement, and active current measurement. No battery or power anomalies noted during testing or in power graph, however unit received with corroded battery tube. 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 batteries end after one day the battery cap was ok and was using batteries from good quality. No harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5