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 a (b)(6)-year-old male child patient experienced high blood glucose levels (over 600 mg/dl) because insulin delivery was hindered due to a kinked cannula, which they tried to treat with a correction injection via multiple daily injection.The infusion set had been used for two days.There was no damage to the infusion set when the package was first opened.Reportedly, two occlusion alarms were received at 5:49 am and at 07:13 am.Subsequently, on (b)(6) 2021, he was admitted to the hospital due to high ketones (diabetic ketoacidosis) and his health care professional assessed it as dangerous/life threatening.During hospitalization, it was noticed that the cannula was kinked, and he was administered fluids of saline, insulin and an unknown drug intravenously (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2021, he was released from the hospital with no permanent damage.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: 11789452
• MDR Text Key: 249449266
• Report Number: 3003442380-2021-00243
• 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
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/29/2021
• Type of Device Usage: N
• Patient Sequence Number: 1