MAUDE Adverse Event Report: AUTOSOFT 30; UNO INSET 30 60/13 GREY TCAP 10PK INT

Lot Number 6001945

Device Problem Material Twisted/Bent (2981)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in canada.It was reported that a 11-years-old male child patient faced a bent cannula on (b)(6) 2023.The patient's blood glucose level reached 34 mmol/l, which they tried to treat with correction injection via multiple daily injection.His ketone level was high which the healthcare professional assessed as dangerous or life-threatening.Moreover, the issue occurred with one infusion set used for ten to twelve hours and the site location was patient's abdomen.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 was available.

• Brand Name: AUTOSOFT 30
• Type of Device: UNO INSET 30 60/13 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18612366
• MDR Text Key: 334635675
• Report Number: 3003442380-2024-00130
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018365
• UDI-Public: 05705244018365
• Combination Product (y/n): Y
• PMA/PMN Number: K061374
• 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: 01/31/2024

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: 6001945
• Initial Date Manufacturer Received: 01/23/2024
• Initial Date FDA Received: 01/31/2024
• Patient Sequence Number: 1