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

Model Number 1002823

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hyperglycemia (1905)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.It was reported that on (b)(6) 2022, an eighteen-year-old male patient's infusion set's tubing detached/broken at site connector prior to insertion.At the time of the event, her blood glucose level was between 295 mg/dl to 340 mg/dl.Moreover, they replaced the infusion set and resumed insulin successfully.No further information available.

• Brand Name: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 BLUE TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15162092
• MDR Text Key: 304876336
• Report Number: 3003442380-2022-00919
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018303
• UDI-Public: 05705244018303
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1002823
• Device Lot Number: 5381149
• Date Manufacturer Received: 07/21/2022
• Patient Sequence Number: 1