The insulin pump passed the rewind, basic occlusion, prime, and displacement tests.The insulin pump received stuck in a motor error alarm loop during bolus delivery.The insulin pump's motor was tested outside of the device and passed.The motor may have had an intermittent failure that was not detected during analysis testing.The displacement test functioning properly.The insulin pump also received with a cracked case at the display window corner, a cracked reservoir tube lip, minor scratches on the lcd window, and a cracked lcd window.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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