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

Lot Number 5385702

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 it was reported that the patient kept on receiving insulin flow blocked alarm which led to high blood glucose level and the patient felt sick/unwell.Therefore, on (b)(6) 2024, the patient was admitted to the hospital with blood glucose level of 578 mg/dl.Moreover, the patient was tested for ketone level.During hospitalization, the patient received insulin drip intravenously.Further, the patient stayed for two days in the hospital.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: 19104421
• MDR Text Key: 340138419
• Report Number: 3003442380-2024-00225
• 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: 04/15/2024

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: 5385702
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1