MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 60/6 GREY TCAP

Model Number 1000273

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient experienced high blood glucose levels and diabetic ketoacidosis.Further, she attempted to manually inject (mainly bolus delivery of less than 3 units) when she noticed she was going into diabetic ketoacidosis.The infusion set had been used for one day.Subsequently, on (b)(6) 2021, she went to the emergency room, with blood glucose level of more than 30 mmol/l which was due to a kinked cannula, where she was treated for her diabetic ketoacidosis (as she shad ketones) through fluid drip intravenously while being admitted into hospital.She stayed in the emergency room for a short period of time (within an hour) and left from there with blood glucose level around 10 mmol/l.Consequently, on the same day ((b)(6) 2021), her blood glucose level had decreased significantly, but she was admitted to the hospital as she was still unwell.During hospitalization, she received drip intravenously and was manually injecting as corrective treatment instructed from her health care professional which resolved the issue.Currently, the patient was still admitted in the hospital.Previously, on (b)(6) 2021, the patient was admitted to the hospital due to the same issue and was released on (b)(6) 2021.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.

• Brand Name: AUTOSOFT 90
• Type of Device: INSET II 60/6 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 11997681
• MDR Text Key: 256167919
• Report Number: 3003442380-2021-00283
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014305
• UDI-Public: 05705244014305
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 09/01/2023
• Device Model Number: 1000273
• Device Lot Number: 5332940
• Date Manufacturer Received: 06/06/2021
• Type of Device Usage: N
• Patient Sequence Number: 1