Currently, it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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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