Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that when she woke up, the infusion set was no longer connected.The infusion set was damaged ripped apart and it was not the adhesive that had caused the issue.It was reported that the infusion set tubing came apart.The site location was reported as top thigh and the pump was worn on the right or same side of set.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The tubing of the infusion set had came apart from the blue donut.It occurred when she was sleeping.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.
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On 09-dec-2019: follow up information was submitted because result of complaint investigation of the returned used device (1 tubing/1 cannula) showed that the tubing was detached from the tubing connector.Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.The patient stated that when she woke up, she was surprised to notice that the infusion set was no longer connected.The infusion set was damaged ripped apart and it was not the adhesive that had caused the issue.The tubing of the infusion set had came apart from the blue donut while she was sleeping.It was reported that the infusion set tubing came apart and at the time of this event patient's blood glucose level was 21 mg/dl which was treated by having food.This issue occurred when she travelled mostly.Reportedly, the patient had experienced low blood glucose level on (b)(6) 2018 and in the month of may, last year.The site location was reported as top thigh and the pump was worn on the right or same side of set.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.On (b)(6) 2018, patient's blood glucose level was dropping down to 21 mg/dl and on (b)(6) 2018 (on the day of this report) patient's blood glucose level was reported to be 141 mg/dl.No further information available.
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