MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 SC1 MECA

Lot Number 5394020

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2024, it was reported that the patient faced an insulin flow block issue as they kept on getting the insulin flow block over and over which led to high blood glucose level.Therefore, they tried to treat it with needle and pen (10 units), but on (b)(6) 2024, between 12:00 pm to 06:00 pm, the patient was admitted to the hospital with blood glucose level of 400 mg/dl.Moreover, the patient tested positive for ketone level.During hospitalization, the patient received insulin drip intravenously.The patient was hospitalized for 4 days and currently, the blood glucose level was 400 mg/dl.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19039551
• MDR Text Key: 339320112
• Report Number: 3003442380-2024-00216
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017573
• UDI-Public: 05705244017573
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5394020
• Date Manufacturer Received: 03/29/2024
• Patient Sequence Number: 1