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

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in israel.On (b)(6) 2024, it was reported that the patient's infusion set disconnected for two hours which led to her high blood glucose level on saturday ((b)(6) 2024).She came home and connected a new infusion set while her blood glucose level was high, administered a bolus and went to sleep.Next day on sunday ((b)(6) 2024) morning, she woke up and was feeling off (sickness, nausea and fatigue), she again administered a bolus and on the same day, the patient went to the emergency room, where she was admitted due to high blood glucose level of 450 mg/dl.She was tested positive for ketone level (1.8 mmol/l).During hospitalization, the patient received shots of insulin and drip as corrective treatment.The patient stayed for one and half days in the hospital.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/6 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18976866
• MDR Text Key: 338549089
• Report Number: 3003442380-2024-00199
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017450
• UDI-Public: 05705244017450
• Combination Product (y/n): N
• 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: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/20/2024
• Patient Sequence Number: 1