MAUDE Adverse Event Report: AUTOSOFT 30; UNO INSET 30 60/13 GREY TCAP 10PK INT

Model Number 1002825

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 a ten-year-old male child patient's infusion set's tubing detached/broken at site connector.At the time of the event, his blood glucose level was 555 mg/dl which they tried to treat with a correction injection via multiple daily injection.Moreover, they replaced the infusion set and resumed insulin successfully.No further information available.

• Brand Name: AUTOSOFT 30
• Type of Device: UNO INSET 30 60/13 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15119632
• MDR Text Key: 302715038
• Report Number: 3003442380-2022-00900
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018365
• UDI-Public: 05705244018365
• Combination Product (y/n): Y
• PMA/PMN Number: K061374
• 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: 07/28/2022

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 Expiration Date: 06/01/2024
• Device Model Number: 1002825
• Device Lot Number: 5349811
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 07/28/2022
• Patient Sequence Number: 1