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

Model Number	MMT-943A600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, the patient's mother reported leakage at the patient's infusion set site.Therefore, they did not discard the reservoir, but changed the site.His blood glucose level was 10.9 mmol/l at the time of the event.Reportedly, the site location was patient's buttocks.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: 13331896
• Report Number: 3003442380-2022-00191
• Device Sequence Number: 16562296
• 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): 01/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 03/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5348388
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/24/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown