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 device received with critical pump error due to moisture damage on electronic assemblies.Unable to perform displacement test, rewind, prime or seating, basic occlusion, force sensor, occlusion, sleep current measurement, active current measurement and selftest due to critical pump errors.The device received with corroded force sensor assembly and moisture damage on motor assembly.
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