MAUDE Adverse Event Report: UNOMEDICAL UM-D MINIMED MIO; UNO INSET II 60/6 SC1 PINK MIMX

Model Number	MMT-923A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Reference number (b)(4).Event occurred in australia it was reported that the patient faced diabetic ketoacidosis event and eventually got hospitalized on (b)(6) 2024 due to insulin flow blocked.Length of hospitalization less than 24 hours.The blood glucose level was 16.3 mmol/l and the patient was treated with correction via injections.Ketones were reported 0.1.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: australia.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: the information in this complaint (b)(4) has been evaluated.The batch 6003873 in question was manufactured at the reynosa site.Investigation process of the complaint was carried out in accordance with work instruction (wi) guidance for visual testing for complaints area version 3.0 and wi guidance for functional testing for complaints area version 2.0 for the code occlusion (source/cause cannot be identified, only use when a specific malfunction cannot be determined).Complaint investigations.Physical samples were formally requested; however, they were not provided.In order to test the product, the reference samples from the lot have been requested.Test results: visual test according to wi version 3.0 on reference samples, 10 samples out 10 samples passed the test.Functional flow test 1 according to wi version 2.0 on reference samples, 10 samples out 10 samples passed the test.Device history record (dhr) review: packing lot 6003873 was manufactured according to the wi version 65 in the line 6, on 18/oct/2023, with a total of (b)(4) units.Gluing of tubing lot 3k02267 was manufactured according to the wi version 56, gluing of tubing in the machine sc02, on 15/oct/2023, with a total of (b)(4) units.Review of the device history record (dhr) showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation were identified related to the malfunction reported, no maintenance events were recorded.Trending: a query was run in database on 05/aug/2025 against malfunction code occlusion (source/cause cannot be identified, only use when a specific malfunction cannot be determined) and lot 6003873 and no other complaint has been registered in database for the same lot 6003873 and malfunction code.Conclusion summary of the related event: as a result of the following: no defect on tests for reference samples, no harm, no non-conformance (nc) raised during production, no other complaint received on the lot in question and malfunction code.No further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., mexico 88736 ; MX 88736
• Manufacturer Contact: ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., mexico 88736
• MDR Report Key: 21166496
• Report Number: 3003442380-2024-36917
• Device Sequence Number: 11846129
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/16/2026
• Device Model Number: MMT-923A
• Device Lot Number: 6003873
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 08/18/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/18/2023
• 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: Required Intervention
• Patient Sex: Unknown