MAUDE Adverse Event Report: MIO ADVANCE; UNO MIO ADV. GREY 60/9 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 finland on (b)(6) 2024, the patient's father reported that his child's infusion sets tubing detached or came loose after the patient was out playing in the snow (sledging) and this issue occurred with four infusion sets.The site location was above patient's buttocks/hip, with the pump on the same side in the trouser pocket.Moreover, the infusion had been used for 3-4 days.Reportedly, the infusions were stored in the medical cabinet.There was stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO ADVANCE
• Type of Device: UNO MIO ADV. GREY 60/9 SC1 10-PK INT
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18736222
• MDR Text Key: 336311593
• Report Number: 8021545-2024-00110
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• 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: 02/20/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/19/2024
• Patient Sequence Number: 1