MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 60/6 SC1 MIMX

Lot Number 6000925

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 china on (b)(6) 2024, the patient reported that the infusion set's tubing was detached.The patient replaced the infusion set and insulin was resumed successfully.No further information was available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 60/6 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18989811
• MDR Text Key: 338746624
• Report Number: 3003442380-2024-00202
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019317
• UDI-Public: 05705244019317
• 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: 03/28/2024

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: 6000925
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 03/27/2024
• Patient Sequence Number: 1