MAUDE Adverse Event Report: AUTOSOFT 90; INSET II 2-PACK 60/6 GREY TCAP

Lot Number UNKNOWN

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 the patient reported that on (b)(6) 2024, the infusion set's tubing that was close to the cannula came out before insertion the issue occurred with one infusion set prior to insertion.The patient replaced the infusion set and insulin was resumed successfully.No further information was available.

• Brand Name: AUTOSOFT 90
• Type of Device: INSET II 2-PACK 60/6 GREY TCAP
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18683593
• MDR Text Key: 335069695
• Report Number: 3003442380-2024-00143
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/12/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 02/12/2024
• Patient Sequence Number: 1