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

Lot Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in france on (b)(6) 2024, it was reported that the tubing came off directly from the catheter during night which led to hyperglycemia.Also, the patient also had sensation of warmth and euphoria.Moreover, the issue occurred after one day of insertion.No further information was 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: 19198857
• MDR Text Key: 341239011
• Report Number: 3003442380-2024-00341
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017573
• UDI-Public: 05705244017573
• Combination Product (y/n): N
• 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: 04/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/04/2024
• Patient Sequence Number: 1