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

Model Number	MMT-943A600
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
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 daughter faced an insulin flow block which started last night.At the time of the event, her blood glucose level was 25 mmol/l, and she changed her site three times.The patient stated that the insulin exited from her infusion set tubing, but the tubing was bent.She pulled the tubing and then the insulin came out.Further, the patient changed full infusion and did not experienced issues with filling tubing.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: 15705835
• Report Number: 3003442380-2022-01092
• Device Sequence Number: 12005201
• 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): 11/01/2022

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: 11/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5368853
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2022
• Initial Report FDA Received Date: 11/01/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown