MAUDE Adverse Event Report: UNOMEDICAL A/S MIO¿ ADVANCE; UNO INSET II 60/6 PCC BLUE MIMX

Model Number	MMT-943
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced infusion set leaking at quick release event on (b)(6) 2024.The infusion set was in use for 1 day.Blood glucose levels reported during the event was 600 mg/dl.The patient was hospitalized for less than 24 hours due to high blood glucose.Patient was treated with intravenous insulin drip.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: united states.
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)(4), 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 5296195, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 5296195 was manufactured according to the work instruction (wi) version 40 and manufactured in the line l4 on 31-oct-2019, 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 4m03050 was manufactured according to the work instruction (wi) version 37 and manufactured in the machine sc03, on 29-oct-2019, 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.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MIO¿ ADVANCE
• Common Device Name: UNO INSET II 60/6 PCC 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: 20631548
• Report Number: 8021545-2024-04331
• Device Sequence Number: 7411488
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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: 09/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5296195
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2019
• 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