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

Lot Number 5409900

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 new zealand.On (b)(6) 2024, it was reported by the patient's mother that her daughter faced an insulin flow block alarm due to which she experienced high blood glucose level.Therefore, on (b)(6) 2024 at 8:24 pm, she was hospitalized due to diabetic ketoacidosis.Her blood glucose level at the time of incident was 26.1 mmol/l and ketones were high (6.7 mmol/l).Further, she had difficulty in breathing.At the time of this report, the patient was in hospital for 3 days.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: 19103591
• MDR Text Key: 340103244
• Report Number: 3003442380-2024-00222
• 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: 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: 5409900
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/15/2024
• Patient Sequence Number: 1