MAUDE Adverse Event Report: UNOMEDICAL A/S MINIMED MIO; UNO INSET II 46/6 SC1 BLUE MIMX

Model Number	MMT-941A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: (b)(6).
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that patient faced infusion set tubing bent with white marks event on 13-jun-2024.No further information available.
Event or Problem Description
To date no additional patient or event details have been received.
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.Complaint investigation: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003875, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6003875 was manufactured according to the work instruction (wi) version 65 and manufactured in the line # 6 on 21/oct/2023 with a total of (b)(4) units.The sub-assembly, gluing of tubing of the lot 3k02269 was manufactured according to the wi version 56 and manufactured in the machine sc02, on 18/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.Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production, one other complaint received on the lot in question, harm code and malfunction code, no further actions are required.This complaint will not require further root cause investigation or 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 46/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19788898
• Report Number: 3003442380-2024-15746
• Device Sequence Number: 15551003
• Product Code: FPA
• UDI-Device Identifier: 05705244020009
• UDI-Public: 05705244020009
• 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): 11/29/2025

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 Expiration Date: 09/01/2026
• Device Model Number: MMT-941A
• Device Lot Number: 6003875
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 11/29/2025
• Initial Report FDA Received Date: 07/21/2024
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2023
• 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
• Patient Sex: Unknown