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	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	05/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in united arab emirates.It was reported that the patient went to an emergency room and eventually hospitalized on (b)(6) 2025 due to hyperglycemia and occlusion alarm event.Blood glucose level was 400 mg/dl at the time of the event.Patient got treated with intravenous (iv) drip.Patient was also found positive for ketones level.Ketones level was 2 mg/dl at the time of the event.The duration of hospitalization was for 24 hours.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.; 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: 22173199
• Report Number: 3003442380-2025-10464
• Device Sequence Number: 9401619
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): N
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/25/2025

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
• 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: 05/25/2025
• Initial Report FDA Received Date: 06/10/2025
• 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
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown