The insulin pump passed displacement test, rewind, basic occlusion and prime/ compromised force sensor tests.The pump was received stuck in motor error alarm loop during bolus/basal delivery.The motor was tested outside of the device and passed.The motor may have had an intermittent failure that was not detected during our testing.Analysis was unable to confirm motor position encoder error alarm due to history file was overwritten.The pump had cracked display window corner, scratched lcd window and cracked reservoir tube lip.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.(b)(4).
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