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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.On (b)(6) 2024, it was reported that the patient faced a leakage of infusion set.The infusion set was used for 1-2 days and site was patient's tummy.No further information was 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: 19283981
• Report Number: 3003442380-2024-01114
• Device Sequence Number: 8305667
• 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

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: 07/01/2026
• Device Lot Number: 6003511
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 05/10/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown