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 on (b)(6) 2022, a (b)(6) year-old male child patient experienced high blood glucose level due to a bent cannula, which they tried to treat with a bolus via the pump.The infusion set had been used for three days.Subsequently, he went to the emergency room as his highest blood glucose level was reported to be more than 500 mg/dl.He stayed there for 4-5 hours and was administered fluids of saline, insulin, and an unspecified mediation (drug name unknown) intravenously as corrective treatment which resolved the issue.On (b)(6) 2022, he was released from the hospital with no permanent damage.Moreover, on (b)(6) 2022, he faced a kinked cannula, and the symptoms/issue were noticed within three hours of insertion.At the time of the event, his blood glucose level was 340 mg/dl and the infusion set had been used for at most about 30-60 minutes.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: 14011570
• MDR Text Key: 288600467
• Report Number: 3003442380-2022-00497
• 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: 04/05/2022

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: 08/01/2024
• Device Model Number: 1001680
• Device Lot Number: 5359470
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/05/2022
• Patient Sequence Number: 1