MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MCAN

Model Number	MMT-943A600
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2022, the patient's mother reported that her child faced an insulin flow blockage due to which the patient experienced high blood glucose level of 23.6 mmol/l.First, the patient experienced high blood glucose level on (b)(6) 2022 and changed the infusion set on the same day prior to the event.Therefore, they tried to treat it with manual injection as they were travelling and took it off for 7 hours.Currently, the patient's blood glucose level was 18.7 mmol/l.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15246824
• Report Number: 3003442380-2022-00956
• Device Sequence Number: 17739945
• Product Code: FPA
• UDI-Device Identifier: 05705244020337
• UDI-Public: 05705244020337
• 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): 08/18/2022

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 Expiration Date: 08/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5360923
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2022
• Initial Report FDA Received Date: 08/17/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown