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

Lot Number 6000788

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in canada.It was reported that a 15-years-old female child patient faced a kinked cannula, three or more hours after insertion due to which she experienced high blood glucose level.Therefore, they tried to treat it with bolus via pump, but on (b)(6) 2023, the patient went to emergency room for 14 hours due to high blood glucose level.Her highest blood glucose level was around 27 mmol/l and had high ketone level which the healthcare professional assessed as dangerous/life-threatening.Moreover, the infusion had been used for four hours and the site location was patient's abdomen.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On the same day ((b)(6) 2023), she was released from the hospital with no permanent damage.Moreover, this similar issue occurred on (b)(6) 2023 and in the first week of december ((b)(6) 2023 or (b)(6) 2023), where the symptoms were noticed three hours after insertion and site was patient's abdomen.Her blood glucose level at the time of event ranged between 6.0 to 10.0 mmol/l.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 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18482204
• MDR Text Key: 332491496
• Report Number: 3003442380-2024-00114
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• 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: 01/10/2024

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: 6000788
• Initial Date Manufacturer Received: 01/08/2024
• Initial Date FDA Received: 01/10/2024
• Patient Sequence Number: 1