MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/6 SC1 MCAN

Lot Number 5413190

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number 1827263 event occurred in canada on 02-feb-2024, it was reported that the patient faced a recurring insulin flow block leading to high blood glucose and she was not feeling good.Therefore, on (b)(6) 2024 at 12:00 pm, she went to emergency room due to high blood glucose level.Also, she had an autoimmune disease which contributed to her hospitalization as well.Her highest blood glucose level was 33 mmol/l.During hospitalization, the patient received insulin and pen intravenously in emergency room as corrective treatment.Further, the patient was released after staying for nine days in the hospital.Currently, her blood glucose level was 12 mmol/l.No further information was available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/6 SC1 MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18729443
• MDR Text Key: 335755875
• Report Number: 3003442380-2024-00152
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• 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: 02/19/2024

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: 5413190
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 02/19/2024
• Patient Sequence Number: 1