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

Lot Number 5389809

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 the patient experienced high blood glucose level.Therefore, on (b)(6) 2023, the patient was hospitalized due to high blood glucose of 1100 mg/dl.While in the hospital, the hospital staff noticed a bent cannula.Moreover, the infusion had been used for three days.Further, she was transferred to the intensive care unit.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.Reportedly, the patient faced similar issue on (b)(6) 2023 and (b)(6) 2024 with 2 infusion sets each which they noticed within 3 hours of insertion.The site location was patient's thigh and abdomen, respectively.Therefore, they tried to treat it with multiple daily injection and correction bolus via pump.Further, they replaced the infusion set and resumed insulin 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 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: 18692530
• MDR Text Key: 335190339
• Report Number: 3003442380-2024-00148
• 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

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5389809
• Date Manufacturer Received: 02/06/2024
• Patient Sequence Number: 1