(b)(4).Event occurred in the united states.It was reported that the patient's infusion set tubing detached from the quick release site.The site location was patient's right abdomen and the pump was located on the right side.Moreover, the infusion set had been used for one day.Reportedly, the infusions were stored in cool dry place.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.On the day of this report ((b)(6) 2020), patient's blood glucose level was 131 mg /dl.No further information available.
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On 23-sep-2020: follow up information was submitted to update health effect - clinical code and health effect - impact code.Moreover, the result of complaint investigation of the returned used device (1 tubing) showed that all the test results were within specifications.Based on the result: medical device problem code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set tubing detached from the quick release site.The site location was patient's right abdomen and the pump was located on the right side.Moreover, the infusion set had been used for one day.Reportedly, the infusions were stored in cool dry place.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.On the day of this report ((b)(6) 2020), patient's blood glucose level was 131 mg /dl.No further information available.
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