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 Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in colombia on (b)(6) 2024, the patient's mother reported that they replaced the damaged infusion set as the pump alerted her to a blocked insulin flow due to which the blood glucose level went up to 400 mg/dl and she changed the infusion set to resolve the issue.Currently, his blood glucose level was 186 mg/dl.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: 19001566
• MDR Text Key: 338885082
• Report Number: 3003442380-2024-00207
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 03/29/2024
• Patient Sequence Number: 1