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

Model Number	MMT-943A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: united arab emirates.
Event or Problem Description
Reference number (b)(4).Event occured in the united arab emirates.The patient was admitted to the emergency room (er) on the evening of (b)(6) 2025, due to high blood glucose (bg).The hospital stay lasted one day.The blood glucose levels were above 600 mg/dl.Patient reported symptoms of dizziness and frequent urination.Patient had ketones of +2.Treatment was given via manual insulin injections.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21916979
• Report Number: 3003442380-2025-07264
• Device Sequence Number: 9021983
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 03/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 06/08/2026
• Device Model Number: MMT-943A
• Device Lot Number: 6002307
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown