MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

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 the patient's infusion set's tubing detached/broken at site connector for four infusion sets.On (b)(6) 2021, her blood glucose level at the time of the event was 400 mg/dl.However, for other three events her blood glucose level was reported as 150-190 mg/dl.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12672161
• MDR Text Key: 277637188
• Report Number: 3003442380-2021-00602
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1002817
• Device Lot Number: 5338564
• Date Manufacturer Received: 10/14/2021
• Type of Device Usage: N
• Patient Sequence Number: 1