Model Number MMT-397A |
Device Problem
Material Twisted/Bent (2981)
|
Patient Problem
Diabetic Ketoacidosis (2364)
|
Event Type
Injury
|
Event Description
|
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported that the patient experienced nausea, vomiting and diabetic ketoacidosis.The blood glucose level was reported to be 1300 mg/dl due to a kinked cannula.Subsequently, on (b)(6) 2021 at 6:00 pm (18:00), the patient was hospitalized and was administered insulin drip as corrective treatment.Reportedly, the patient was hospitalized for three days.Currently, the patient's blood glucose level was 108 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
|
|
Event Description
|
On 30-mar-2022 an: follow up information was submitted to update the unique identifier (udi) number and awareness date.Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, it was reported that the patient experienced nausea, vomiting and diabetic ketoacidosis.The blood glucose level was reported to be 1300 mg/dl due to a kinked cannula.Subsequently, on (b)(6) 2021 at 6:00 pm (18:00), the patient was hospitalized and was administered insulin drip as corrective treatment.Reportedly, the patient was hospitalized for three days.Currently, the patient's blood glucose level was 108 mg/dl.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.
|
|
Search Alerts/Recalls
|
|