MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. I-PORT ADVANCE; I-PORT ADVANCE 6 MM 2-PACK

Model Number	MMT-100T
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: brazil.Since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in brazil.It was reported that the patient faced an infusion set leakage event on (b)(6) 2025.The leakage was at the top of the septum.Blood glucose level was displayed high at the time of the event.No further information available.

• Brand Name: I-PORT ADVANCE
• Common Device Name: I-PORT ADVANCE 6 MM 2-PACK
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, mexico 4320
• MDR Report Key: 22696816
• Report Number: 3003442380-2025-12226
• Device Sequence Number: 8945273
• Product Code: FPA
• UDI-Device Identifier: 05705244009356
• UDI-Public: 05705244009356
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K120337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-100T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Initial Report FDA Received Date: 08/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown