Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that a couple of weeks ago, the tubing clip disconnected from the site, underneath a car as he rolled over and heard it disconnect and it seemed like by just squeezing one side of the lock, while doing mechanic work.The site location was on his left side of his abdomen and the pump was located on the right hip.The infusion had been used since (b)(6) 2021 (09:30 pm).Reportedly, the infusion sets 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 the patient's body.Currently, his blood glucose level was 95 mg/dl.No further information available.
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On 24-may-2021: follow up information was submitted to update the brand name, common device name, unique identifier (udi) number, pma/510(k) number and the result of complaint investigation of the returned used device (1 set inserted) showed that all the test results were within specification.Based on the result: medical device problem code, component 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.On (b)(6) 2021, it was reported that a couple of weeks ago, the tubing clip disconnected from the site, underneath a car as he rolled over and heard it disconnect and it seemed like by just squeezing one side of the lock, while doing mechanic work.The site location was on his left side of his abdomen and the pump was located on the right hip.The infusion had been used since (b)(6) 2021 (09:30 pm).Reportedly, the infusion sets 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 the patient's body.Currently, his blood glucose level was 95 mg/dl.No further information available.
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