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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The insulin pump received with intermittent button response and button error alarm due to corroded keypad traces.No moisture damage on the lcd board, motherboard, interface board, remote frequency board, motor, vibrator and battery tube assembly during visual inspection.The insulin pump was received with cracked case at the display window corner, cracked reservoir tube lip, minor scratches on lcd window and cracked battery tube threads.
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