MAUDE Adverse Event Report: SURE-T PARADIGM; UNO CONTACT DETACH G29 80/6 SC1 MIMX

Lot Number 6003284

Device Problem Leak/Splash (1354)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4) event occurred in canada on (b)(6) 2024, it was reported by child's mother that her child faced an infusion set leakage.The blood glucose level of child was over 20mmol/l.Moreover, the infusion set was used for one day.No further information was available.

• Brand Name: SURE-T PARADIGM
• Type of Device: UNO CONTACT DETACH G29 80/6 SC1 MIMX
• Manufacturer Contact: aaholmvej 1-3; osted city; lejre, 4320
• MDR Report Key: 19196943
• MDR Text Key: 341239232
• Report Number: 3003442380-2024-00340
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019348
• UDI-Public: 05705244019348
• 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: 04/27/2024

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: 6003284
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/26/2024
• Patient Sequence Number: 1