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

Lot Number 5381323

Device Problem Leak/Splash (1354)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number: (b)(4).Event occurred in canada.It was reported that on 14-dec-2023 (2 events) and 15-dec-2023 (1 event), the patient faced a leaking cannula at the site due to which she experienced high blood glucose level.Her highest blood glucose level due to the incident was 28 mmol/l and had high ketone level which the healthcare professional identified as dangerous or life-threatening.The issues occurred with three similar types of infusion sets used for four hours for event one, two hours for event two and seven hours for event three.Therefore, they tried to treat it with multiple daily injection.Moreover, similar issue occurred on (b)(6)2023.Therefore, the patient went to emergency room for three days (staff wanted to admit her to hospital but due to since there was no open bed, she remained in emergency room).Her highest blood glucose level due to the incident was 28 mmol/l and had high ketone level which the healthcare professional assessed as dangerous or life-threatening.Also, the infusion set was used for 10 hours.During hospitalization, the patient received fluids of saline, insulin, anti-nausea medication and potassium as corrective treatment which resolved the issue.On (b)(6) 2023, the patient was released from the hospital with no permanent damage.After being released, she replaced the infusion set and insulin was resumed successfully.According to complaint investigation performed on the reference samples, in one sample, it was found that the cannula part was found to be leaking at the upper membrane.According to complaint investigation performed on the reference samples, in one sample, it was found that the cannula part was found to be leaking at the upper membrane.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: 18666339
• MDR Text Key: 334833516
• Report Number: 3003442380-2024-00141
• 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: 02/08/2024

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: 5381323
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/08/2024
• Patient Sequence Number: 1