MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MIMX

Lot Number	5404803
Medical Device Problem Code	Infusion or Flow Problem (2964)
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 the australia on (b)(6) 2024, it was reported by the patient's father that faced an issue with the pump.The pump was detected an occlusion that prevents the insulin flow and insulin blocked alarm was noticed.The patient was disconnected the site and remove reservoir from pump.In order to troubleshoot the patient was requested to remains disconnected and manually push insulin slowly through tubing with plunger.The issue was occurred during therapy.Insulin exits the tubing was noticed.The patient was requested to change the infusion set and reservoir.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19295136
• Report Number: 3003442380-2024-00579
• Device Sequence Number: 7069899
• Product Code: FPA
• UDI-Device Identifier: 05705244019911
• UDI-Public: 05705244019911
• Combination Product (Y/N): N
• 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): 05/11/2024

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 Expiration Date: 11/01/2025
• Device Lot Number: 5404803
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 05/11/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown