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.
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The insulin pump powered up properly after battery installation.Unit received with operating currents within spec.Unit passed self test, rewind, seating, basic occlusion test, occlusion test, force sensor test and displacement test.Unit was tested with a water fill reservoir.Units left on status screen matched properly with units left on test reservoir.No prime fill anomaly noted.Unit received with corroded battery tube.Unit received with minor scratches on lcd window.
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