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

Lot Number 6003889

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 poland it was reported the patient's infusion set's tubing detached close to the site location while sleeping.The site location was the patient's leg.The infusion set had been used for the second day.Reportedly, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.They were unsure whether there was any stress or pull on the tubing and the pump was not dropped with the set connected to the 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: 19189364
• MDR Text Key: 341460364
• Report Number: 8021545-2024-00155
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 6003889
• Date Manufacturer Received: 04/09/2024
• Patient Sequence Number: 1