MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Lot Number 5373672

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in denmark the patient's mother reported that on (b)(6) 2023, her 3-year-old male child patient's infusion set's cannula bent during insertion/wear, due to which he experienced high blood glucose level of 29 mmol/l.Therefore, they treated it with administering insulin at home and he recovered after a while.Moreover, this issue occurred 2-3 times per year approximately.His blood glucose level would range between 20-30 mmol/l and tested for blood ketone levels (1-2 mmol/l).Further, they treated it by changing the cannula and giving extra insulin to resolve the issue.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 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18665835
• MDR Text Key: 335070039
• Report Number: 3003442380-2024-00138
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5373672
• Date Manufacturer Received: 01/26/2024
• Patient Sequence Number: 1