MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

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 a patient experienced a kinked cannula issue, but on (b)(6) 2021, the patient changed the infusion set and the blood glucose level was reported as 21 mmol/l which was rising.Moreover, in the morning of (b)(6) 2021 at 1:45 am, the patient's blood glucose level was reported as more than 30 mmol/l, as the cannula was kinked.They tried to treat this issue by a correction bolus.On the same day ( (b)(6) 2021), the patient was admitted to the hospital with high blood glucose level of over 30 mmol/l and had ketones which the health care professional assessed as dangerous/life threatening.During hospitalization, the patient received kalium infusion as corrective treatment which resolved the issue.Further, the pump was reactivated during the stay in the hospital.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: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13103216
• MDR Text Key: 283294553
• Report Number: 3003442380-2021-00877
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• 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: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/01/2023
• Device Model Number: 1002817
• Device Lot Number: 5338486
• Date Manufacturer Received: 12/14/2021
• Patient Sequence Number: 1