(b)(4). Unit p-cap/reservoir locked properly in place. Unit received with cracked case (battery tube) and cracked battery tube threads. Unit received with unresponsive buttons, problem isolated to keypad assembly. Unable to perform displacement test or selftest due to unresponsive keypad. Unit received with corroded electronic assemblies. 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 the insulin pump got broken at the back of case. Insulin pump was not dropped. Insulin pump was replaced no harm requiring medical intervention was reported. The insulin pump will be returned for analysis.
Patient Sequence No: 1, Text Type: D, B5