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 (b)(6).It was reported that a (b)(6) female child patient experienced high blood glucose level due to a kinked cannula on the infusion site.Therefore, she tried to treat it with multiple daily injection and changed the site, but the second site was also kinked, it turned out.Subsequently, on (b)(6) 2021, the patient went to the emergency room due to high blood glucose level.Her highest blood glucose level was 520 mg/dl and had moderate ketone levels which the health care professional assessed not to be dangerous/life threatening.Moreover, the infusion was changed the same day when the patient was admitted to the emergency room.While in the emergency room, she received fluids of saline, insulin, and unspecified intravenous medication (drug name unknown) as corrective treatment which resolved the issue.After staying for three hours in the emergency room, on the same day ((b)(6) 2021), the patient was released 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: 12073795
• MDR Text Key: 258627730
• Report Number: 3003442380-2021-00300
• 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: 06/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2024
• Device Model Number: 1001680
• Device Lot Number: 5338628
• Date Manufacturer Received: 06/17/2021
• Type of Device Usage: N
• Patient Sequence Number: 1