MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/9 GREY TCAP 10PK INT

Model Number 1001681

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 multiple times from 30-jun-2022 to 04-jul-2022, the patient's infusion set's tubing detached/broken at site connector, and they replaced it immediately.At the time of the incident, his blood glucose level was averaged 100 mg/dl.Moreover, they replaced the infusion set and resumed insulin successfully.

• Brand Name: AUTOSOFT XC
• Type of Device: UNO INSET I 60/9 GREY TCAP 10PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15049901
• MDR Text Key: 302851479
• Report Number: 3003442380-2022-00884
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016651
• UDI-Public: 05705244016651
• 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: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1001681
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/12/2022
• Patient Sequence Number: 1