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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Customer's mother reported via phone call high blood glucose and issues with the insulin pump.Customer's blood glucose level was 448 mg/dl.Customer experienced ketones, sweatiness and treated their high blood glucose via insulin pump.Customer's healthcare provider advised to treat their high blood glucose via insulin pen and remove the device.Customer was assisted with removing the reservoir, rewinding the insulin pump, reinserting the reservoir and running a manual prime.Customer performed and passed the high pressure test.Customer was advised to change out their entire set, reservoir, insulin and treat their high blood glucose per healthcare provider's instructions.
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