MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 BLUE MIMX

Model Number	MMT-945A600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient's father reported that his son had another instance of tubing detachment last night while sleeping.The pump was in a soft toy which he cuddles.The infusion set had been used less than a day and they are in a closed cupboard in his bedroom.Further, the pump was not dropped and there was no stress on the tubing.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12959066
• Report Number: 3003442380-2021-00794
• Device Sequence Number: 13891022
• Product Code: FPA
• UDI-Device Identifier: 05705244020368
• UDI-Public: 05705244020368
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/08/2021

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 Expiration Date: 12/01/2024
• Device Model Number: MMT-945A600
• Device Lot Number: 5341368
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 12/08/2021
• Patient Sequence Number: 1
• Patient Sex: Unknown