Failure analysis noted that the pump passed the rewind, basic occlusion, and prime/ compromised force sensor and displacement tests.The pump was received stuck in motor error alarm loop during bolus delivery and motor position encoder error alarm confirmed in the history file.The motor was tested outside to the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Pump received with cracked reservoir tube lip and cracked battery tube threads.Note: this is a remediation mdr.Medtronic diabetes implemented revised mdr reportability criteria effective on (b)(6) 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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