MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MIMX

Lot Number 5360912

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 (b)(6).On (b)(6) 2022, it was reported the patient's infusion set's tubing had detached close to the connector where the patch is (quick release), where tubing joins the needle.The site location was the patient's abdomen, and the pump was located around the waist in the center.The first event occurred while the patient was sleeping, and the infusion had been used for about second day.However, for the second event it happened while sitting and watching television and the infusion had been used for 30 minutes.The infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13897424
• MDR Text Key: 287902636
• Report Number: 3003442380-2022-00451
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• 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: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5360912
• Date Manufacturer Received: 03/11/2022
• Patient Sequence Number: 1