MAUDE Adverse Event Report: AUTOSOFT¿ XC; UNO INSET I 60/9 GREY TCAP 10PK INT

Model Number 1001681

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) 2021, the patient faced a kinked cannula symptoms/issue noticed three hours after insertion of the infusion set due to which she experienced high blood glucose level which they tried to treat with multiple daily injection, but on the same day ((b)(6)-2021), she was admitted to the emergency room and was subsequently hospitalized due to high blood glucose level.Her highest blood glucose level was 531 mg/dl.The infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin and unspecified medication intravenously as corrective treatment which resolved the issue.On (b)(6) 2021, she was released from the hospital with no permanent damage.Moreover, it was reported that the kinked cannula issue occurred with three infusion sets and her blood glucose level was 135 mg/dl at the time of the event.Further, they replaced the infusion set and 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 60/9 GREY TCAP 10PK INT
• MDR Report Key: 12487279
• MDR Text Key: 271870941
• Report Number: 3003442380-2021-00477
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016651
• UDI-Public: 05705244016651
• 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: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 1001681
• Device Lot Number: 5345439
• Date Manufacturer Received: 09/09/2021
• Type of Device Usage: N
• Patient Sequence Number: 1