(b)(4).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.The insulin pump was received with missing retainer, missing reservoir tube o-ring, and scratched case.The pump was also received with a cracked select button keypad overlay, keypad overlay scratched, pillowing keypad overlay, and minor scratched lcd window.The unit was unable to perform the displacement test due to missing retainer.
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