MAUDE Adverse Event Report: UNOMEDICAL A/S MIO¿ ADVANCE; UNO INSET II 80/6 SC1 GREY MIMX

Model Number	MMT-965A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in australia.It was reported that patient faced an insulin flow block alarm on (b)(6) 2024.During troubleshooting insulin was not exited and pump alarmed.No further information available.
Additional Manufacturer Narrative
E1:patient country: australia.Patient city:(b)(6).
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 per revision 21 of procedure (b)(6), a child investigation is not required to document the dhr review for a type 2 reportable complaint.However, the child was created to allow the parent record to advance to review and summary.Since it was created, the dhr review was documented within the child.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003930, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6003930 was manufactured according to the work instruction (wi) version 34 and manufactured in the line l6 on 24-oct-2023, with a total of (b)(4) units.Review of the 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.The sub-assembly: gluing of tubing lot 3k03755 was manufactured according to the work instruction (wi) version 57 and manufactured in the machine sc02, on 22-oct-2023, with a total of (b)(4) units.Review of the 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: no non conformance (nc) raised during production related to complaint code, no trend identified for 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.

• Brand Name: MIO¿ ADVANCE
• Common Device Name: UNO INSET II 80/6 SC1 GREY 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: 20513317
• Report Number: 8021545-2024-04253
• Device Sequence Number: 7082410
• Product Code: FPA
• UDI-Device Identifier: 05705244020153
• UDI-Public: 05705244020153
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K173879
• 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,Followup
• Report Date (Section B): 11/26/2025

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: 09/22/2026
• Device Model Number: MMT-965A
• Device Lot Number: 6003930
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2023
• 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