MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED MIO; UNO INSET II 60/6 SC1 BLUE MIMX

Model Number	MMT-943A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	04/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in united arab emirates.It was reported that the patient experienced an event of infusion set leakage from the cannula.High blood glucose resulting from the event was addressed using correction bolus via pump.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.The information in this complaint (b)(4) has been evaluated.The batch 6006887 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 and wi guidance for functional testing for complaints area version 2 for the code leakage from infusion site (specific cause not identified).Complaint investigations.Photo/sample was 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 on reference samples, 10 samples out 10 samples passed the test.Functional air flow test 1 flow according to wi version 2 on reference samples, 5 samples out 10 samples passed the test, the other 5 samples cannot be tested due to the samples were used in special investigation.Functional air leak test 2 according to wi version 2 on reference samples, 5 samples out 10 samples passed the test, the other 5 samples cannot be tested due to the samples were used in special investigation.Device history record (dhr) review: the lot 6006887 was manufactured according to the wi version 71 manufactured in the line l-9, li94, on 02/may/2024, 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 were identified; no maintenance events were recorded.Trending: a query was run in database on 06/jun/2025 against malfunction code leakage from infusion site (specific cause not identified) and lot 6006887 and no other complaints have been registered in database for the same lot and malfunction code.Conclusion summary of the related event: no harm reportable, no defect on tests, no non-conformance (nc) raised during production and malfunction code, no further actions are required.Therefore, this issue will be monitored through the post marketing survillence (pms) product trends and malfunction according to the on market quality review (omqr) procedure.

• Brand Name: MINIMED MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; avenida fomento industrial lot; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 21993019
• Report Number: 3003442380-2025-08411
• Device Sequence Number: 17262679
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K061374
• 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): 06/13/2025

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-943A
• Device Lot Number: 6006887
• 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: 04/12/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2024
• 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