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

Lot Number 5390052

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in france.It was reported by patient's mother that on (b)(6) 2023, that her child faced a bent cannula leading to high blood glucose level of 400 mg/dl with ketones.She applied medical protocol and injected 3 units of insulin with a pen and replaced the infusion set with a new one.Similar issue occurred with second infusion set when blood glucose level grew to 400 mg/dl with ketones.Again, she applied medical protocol and removed the infusion set and noticed a bent cannula.Further, they replaced the infusion set with a new one.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 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18391611
• MDR Text Key: 331295513
• Report Number: 3003442380-2023-00415
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5390052
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/26/2023
• Patient Sequence Number: 1