One opened/used infusion set was inspected and manual prime test was performed using a new lab reservoir along with an insulin pump.The infusion set failed per specifications due to being occluded at the tubing quick release connection septum side.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on july 1, 2014.Subsequently, medtronic diabetes conducted a one year retrospective review of complaints.This event was retrospectively identified to be reportable based on the revised mdr reportability criteria.
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