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

Lot Number	6003511
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.On (b)(6) 2024, the patient reported that the infusion set had been leaked and location of leakage was at site.Patient's blood glucose at time of incident was 20 mmol/l.Patient was treated with manual injection.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19298970
• Report Number: 3003442380-2024-01005
• Device Sequence Number: 5665454
• Product Code: FPA
• UDI-Device Identifier: 05705244020009
• UDI-Public: 05705244020009
• Combination Product (Y/N): N
• 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): 05/10/2024

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: 09/01/2026
• Device Lot Number: 6003511
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2024
• Initial Report FDA Received Date: 05/13/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown