MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

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.It was reported that the patient faced multiple bent cannula issues since starting the pump a year ago.First, it was stated that the patient faced a bent cannula symptoms/issue noticed after 3 hours after insertion due to which she experienced high blood glucose level which they tried to treat it with multiple daily injection, but on (b)(6) 2021 (the patient could not recall the exact date), the patient was hospitalized due to high blood glucose level (over 400 mg/dl) and was transferred to the intensive care unit.Moreover, the infusion set had been used for three days.During hospitalization, she received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On an unknown date in the month of (b)(6) 2021, the patient was released from the hospital with no permanent damage.Secondly, it was reported that the patient faced a bent cannula due to which she experienced high blood glucose level which they tried to treat it with multiple daily injection, but on (b)(6)2021, the patient was hospitalized due high blood glucose level and was transferred to the intensive care unit.Moreover, the infusion set had been used for three days.During her stay in the emergency room, she received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2021, the patient was released from the hospital, but the patient experienced a minor heart attack.Further, they replaced the infusion set and insulin was resumed successfully.Thirdly, she again faced a bent cannula due to which she experienced high blood glucose level which they tried to treat it with multiple daily injection, but on (b)(6) 2022, the patient went to the emergency room due to high blood glucose level.Moreover, the infusion set had been used for three days.During her stay in the emergency room, she received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2022, after 24 hours, the patient was released from the hospital with no permanent damage.Further, she added these bent cannulas have caused four hospitalizations: two with diabetic ketoacidosis and one with a minor heart attack.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 XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14600525
• MDR Text Key: 293334682
• Report Number: 3003442380-2022-00735
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001680
• Device Lot Number: 5353197
• Date Manufacturer Received: 05/26/2022
• Patient Sequence Number: 1