MAUDE Adverse Event Report: MIO ADVANCE; UNO MIO ADV. GREY 60/6 SC1 10-PK INT

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 switzerland.On (b)(6) 2024, it was reported that patient's infusion set's tubing was detached and leaked at the part where it attaches.The infusion had been used for two days.Reportedly, there was no stress or pull on the tubing and the pump was dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/6 SC1 10-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18847094
• MDR Text Key: 337149719
• Report Number: 8021545-2024-00122
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• Combination Product (y/n): N
• PMA/PMN Number: K173879
• 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: 03/06/2024

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: 02/29/2024
• Initial Date FDA Received: 03/06/2024
• Patient Sequence Number: 1