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

Lot Number 6002867

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 on (b)(6) 2024, the patient's infusion set's tubing detached from the connector which he noticed prior to insertion when packaging first opened, and this issue occurred with two infusion sets.The patient's blood glucose level was 118 mg/dl at the time of the event.Further, they replaced the infusion set and insulin was resumed successfully.No further information available.

• 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: 18939069
• MDR Text Key: 338068503
• Report Number: 3003442380-2024-00194
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016651
• UDI-Public: 05705244016651
• Combination Product (y/n): N
• 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: 03/20/2024

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 Lot Number: 6002867
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 03/20/2024
• Patient Sequence Number: 1