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 an (b)(6) female child patient experienced high blood glucose level due to a bent cannula, sometime in the end of (b)(6) 2021.Therefore, they tried to treat it with bolus via the pump and multiple daily injection, but on an unknown date, the patient went to the emergency room due to high blood glucose level.Her highest blood glucose level was 400 mg/dl and she had high ketone levels.Moreover, the infusion set had been used for one day.While in the emergency room, the patient stopped using the pump after going to the emergency room.She had the flu and her health care professional told her to only use insulin pens.Further, during hospitalization, the patient received intravenous drip as corrective treatment which resolved the issue.After staying for eight hours in the emergency room, on the same day (the patient could not recall the exact date), 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: 12767659
• MDR Text Key: 280448391
• Report Number: 3003442380-2021-00639
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/01/2024
• Device Model Number: 1001680
• Device Lot Number: 5345500
• Initial Date Manufacturer Received: 10/30/2021
• Initial Date FDA Received: 11/08/2021
• Patient Sequence Number: 1