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

Model Number MMT-242A

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 (b)(6).On (b)(6) 2022, it was reported that the patient's infusion set's tubing detached close to site location.The site location was the patient's abdomen, and the pump was in the right pocket.The infusion set had been used for less than one day.The infusions were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the 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: 14082410
• MDR Text Key: 289521112
• Report Number: 8021545-2022-00136
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018877
• UDI-Public: 05705244018877
• 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: 04/12/2022

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 Model Number: MMT-242A
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/01/2022
• Initial Date FDA Received: 04/12/2022
• Patient Sequence Number: 1