MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED MIO; UNO INSET II 80/9 SC1 GREY MIMX

Model Number	MMT-975A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in australia.It was reported that the patient faced an insulin flow blocked alarm event on (b)(6) 2025.The blockage was in the tubing.No further information available.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11.
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.Revision 21 of 3709030 does not require a complaint that is type 2 reportable to open a child investigation.This child investigation was opened against a previous revision of (b)(4).Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6006035, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6006035 was manufactured according to the work instruction (wi) version 69 and manufactured in the line inset 9 on 13/mar/2024, with a total of (b)(4) units.Glue-tubing lot: the lot 4c00029 was manufactured according to the wi version 61 and manufactured in the machine sc09 on 12/mar/2024, with a total of (b)(4) units.The lot 4c03170 was manufactured according to the wi version 61 and manufactured in the machine sc09 on 15/mar/2024, with a total of (b)(4) units.Review of the device history record (dhr) showed that a non-conformance (nc) 1844576 was opened during the sterilization processes actions were required.Therefore, device history record (dhr) showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Conclusion summary of complaint investigation: as a result of the following: one non-conformance (nc) raised during sterilization process unrelated to complaint code and one extended was raised during the process unrelated to the malfunction reported, therefore, no non-conformance (nc) raised during production related to complaint 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.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY 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: 22539203
• Report Number: 3003442380-2025-11698
• Device Sequence Number: 7903898
• Product Code: FPA
• UDI-Device Identifier: 05705244020184
• UDI-Public: 05705244020184
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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-975A
• Device Lot Number: 6006035
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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