(b)(4).Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.The insulin pump involved in this event is the paradigm real-time veo 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.
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Findings: blank display due to moisture damage on the lcd board.Unable to confirm unexpected battery power loss/off no power alarm or perform the operating currents measurement, self test, unexpected alarm error test, displacement, rewind, basic occlusion, occlusion, prime and excessive no delivery tests due to blank display anomaly.Pump had cracked case at display window corner, reservoir tube lip and minor scratched display window.The insulin pump involved in this event is the paradigm real-time veo 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.
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