Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that while unwinding the infusion set's tubing before insertion, it accidently pulled out the set at the tubing connector and this issue occurred a couple of weeks ago.Currently, patient's blood glucose level was 152 mg/dl.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.
|
On 12-may-2021: follow up information was submitted to update the lot number, expiry date and awareness date.Moreover, the result of complaint investigation of the returned used device (2 sets) 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 while unwinding the infusion set's tubing before insertion, it accidently pulled out the set at the tubing connector and this issue occurred a couple of weeks ago.Currently, patient's blood glucose level was 152 mg/dl.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.
|