MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED MIO; UNO INSET II 60/6 SC1 BLUE MIMX

Model Number	MMT-943A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in united arab emirates.It was reported that the patient experienced an event of insulin flow blocked on (b)(6) 2025 leading to high blood glucose (400mg/dl).The site of insertion was abdomen.No further information available.
Additional Manufacturer Narrative
E1 : patient city : (b)(6).Patient country : united arab emirates.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; avenida fomento industrial lot; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1 - 3; osted, 4320 lejre; denmark, 4320
• MDR Report Key: 21974378
• Report Number: 3003442380-2025-07927
• Device Sequence Number: 15750120
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 04/11/2025

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-943A
• Device Lot Number: 6006887
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Initial Report FDA Received Date: 05/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/02/2024
• 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