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

Lot Number UNKNOWN

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 germany.On (b)(6) 2023, it was reported that the patient faced an insulin flow block due to which the patient experienced high blood glucose level, felt sick/unwell, weak and confusion.Therefore, on saturday ((b)(6) 2023), the patient was admitted to the hospital due to high blood glucose level.The patient's highest blood glucose level at the time of incident was 1200 mg/dl and tested positive for ketone level.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After spending 3 days in the hospital, the patient was released.No further information was 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: 18481994
• MDR Text Key: 332491968
• Report Number: 3003442380-2024-00113
• 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: 01/10/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/10/2024
• Patient Sequence Number: 1