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

Lot Number	6000281
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mdr 3003442380-2024-02891 - device 2 of 3.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in canada.It was reported that patient faced three infusion set leaking from site on (b)(6) 2024.No further information available.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19379104
• Report Number: 3003442380-2024-02891
• Device Sequence Number: 20717405
• Product Code: FPA
• UDI-Device Identifier: 05705244020306
• UDI-Public: 05705244020306
• 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): 05/23/2024

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: 02/01/2026
• Device Lot Number: 6000281
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 05/23/2024
• Date Device Manufactured: 03/13/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown