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	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 that her son had to go over six infusion sets from sunday ((b)(6) 2022) till today due to an insulin flow blocked.His blood glucose level was 24 mmol/l at the time of incident.Currently, the patient was sleeping as he was not feeling well, and his mother had to go to pick him up from work as he was unwell.The patient experienced diarrhea, headache, vomiting and his blood glucose level was very elevated.At the time of this report, his blood glucose level was 8 mmol/l after taking few needles.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: 14217091
• Report Number: 3003442380-2022-00597
• Device Sequence Number: 4194075
• 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): 04/27/2022

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: 05/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5352660
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/27/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown