MAUDE Adverse Event Report: AUTOSOFT 30; INSET 30 2-PACK 60/13 GREY TCAP

Model Number 1000283

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) 2021, a (b)(6)-year-old male child patient's infusion set's tubing detached/broken at site connector.At the time of the event, her blood glucose level ranged from 260 mg/dl to 400 mg/dl.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• Brand Name: AUTOSOFT 30
• Type of Device: INSET 30 2-PACK 60/13 GREY TCAP
• MDR Report Key: 12597320
• MDR Text Key: 275389402
• Report Number: 3003442380-2021-00552
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244014664
• UDI-Public: 05705244014664
• 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: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2024
• Device Model Number: 1000283
• Device Lot Number: 5349803
• Date Manufacturer Received: 09/28/2021
• Type of Device Usage: N
• Patient Sequence Number: 1