(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 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.
|
Device p-cap or reservoir locked properly in place.Device received with cracked case (battery tube), cracked case-corner of belt clip rails, and cracked battery tube threads.Device received with critical pump error due to moisture damage to force sensor.Device received with corroded electronic assemblies and corroded motor home switch.Device unable to perform displacement test, rewind, prime or seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement, and self test due to critical pump error (open book image) alarm.
|