MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 BLUE TCAP 10PK INT

Model Number 1001683

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) old female child patient experienced high blood glucose level due to a bent cannula.Therefore, they tried to treat it with a bolus via the pump, but on (b)(6) 2022, the patient went to the to the emergency room due to high blood glucose level.Her highest blood glucose level was 480 mg/dl and she had high ketone levels.Moreover, the infusion set had been used for every 3 days.During her stay in the emergency room, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.After spending 8 hours in the emergency room, on the same day ((b)(6) 2022), the patient was released from the hospital with no permanent damage.Further, they replaced the infusion set and insulin was resumed successfully.Since that date ((b)(6) 2022), the patient faced bent cannula symptoms/issue noticed three hours after insertion and this issue occurred with six infusion sets.Her blood glucose level was between 380-499 mg/dl.The infusion had been used for 3 hours to 2 days.Further, they replaced the infusion set and the insulin was resumed successfully.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 BLUE TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14386903
• MDR Text Key: 291746117
• Report Number: 3003442380-2022-00655
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016712
• UDI-Public: 05705244016712
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1001683
• Device Lot Number: 5359516
• Date Manufacturer Received: 05/03/2022
• Patient Sequence Number: 1