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

Lot Number 6001930

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 patient was hospitalized in the year 2023 due to a bent cannula leading to diabetic ketoacidosis (she also had bad arthritis in hand).On (b)(6) 2023, on (b)(6) 2024 and on (b)(6) 2024, the patient faced a kinked cannula with three similar types of infusion sets due to which she experienced high blood glucose level.The infusion had been used for one day and the issue occurred within three or more hours after insertion.Also, the site location was patient's abdomen.Her blood glucose level was 524 mg/dl due this issue.Therefore, she tried to treat it with multiple daily injection and changed the infusion set on (b)(6) 2024, but she could not resolve the issue and on (b)(60 2024, the patient first went to emergency room and was subsequently hospitalized due to high blood glucose level due to high blood glucose level.She had moderate ketone level which her healthcare professional did not assess as dangerous or life-threatening.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.At the time of this report, the patient was not released from the hospital.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 was 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: 18683674
• MDR Text Key: 335070278
• Report Number: 3003442380-2024-00145
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/12/2024

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 Lot Number: 6001930
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/12/2024
• Patient Sequence Number: 1