MAUDE Adverse Event Report: VARISOFT; UNO COMFORT 110/17 TCAP 10PK INT

Model Number 1002832

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 the united states.It was reported that on (b)(6) 2022, the patient's infusion set's tubing detached/broken at site connector.This issue occurred with three infusion sets.Reportedly, his blood glucose was 127 mg/dl.The infusion set had been used for one day.Further, they replaced the infusion set and resumed insulin successfully.No further information available.

• Brand Name: VARISOFT
• Type of Device: UNO COMFORT 110/17 TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13889733
• MDR Text Key: 288021943
• Report Number: 8021545-2022-00121
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018846
• UDI-Public: 05705244018846
• Combination Product (y/n): Y
• PMA/PMN Number: K162812
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002832
• Device Lot Number: 5359423
• Date Manufacturer Received: 03/08/2022
• Patient Sequence Number: 1