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 (b)(6).On (b)(6) 2021, the patient's mother reported that her (b)(6) son's infusion set's tubing detached/broken at the site connector.Therefore, his blood glucose level was between 300-400 mg/dl at the time of the event.Moreover, they replaced the infusion set and insulin was resumed 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: 12671262
• MDR Text Key: 277647455
• Report Number: 3003442380-2021-00609
• 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
• 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 Expiration Date: 04/01/2024
• Device Model Number: 1002825
• Device Lot Number: 5349808
• Date Manufacturer Received: 10/12/2021
• Type of Device Usage: N
• Patient Sequence Number: 1