MAUDE Adverse Event Report: UNOMEDICAL UM-D MIO; UNO INSET II 60/6 SC1 PINK MIMX

Model Number	MMT-923A
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H1: since no lot number is available.A detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends picked up, this would flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that the patient faced an event on (b)(6)2024 where there was a ball of plastic on the end of tip of cannula almost like cannula has been sealed.The blood glucose level of the patient was 20.4 mmol/l which was treated by correction bolus via pump and multiple daily injection.Moreover, the site was patient's abdomen and issue occurred within three or more hours after insertion.No further information available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted manufacturing date under h4.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 6006078 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 foreign matter within product (only use where the foreign matter is within the insulin pathway) 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 test 1: air flow according to wi version 2 on reference samples, reference samples passed the test.Device history record (dhr) review: the lot 6006078 was manufactured according to the wi version 69 and packaging in the machine ll101, on 16/mar/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 19/aug/2025 against malfunction code foreign matter within product (only use where the foreign matter is within the insulin pathway) and lot 6006078 and no more complaint have been registered in database for the same lot and malfunction code.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples, 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
• Common Device Name: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer (Section D): UNOMEDICAL UM-D; ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736 ; MX 88736
• Manufacturer Contact: ave. fomento industrial l9 m3; parque industrial del norte; reynosa , tamps., 88736
• MDR Report Key: 21629499
• Report Number: 3003442380-2025-03819
• Device Sequence Number: 15684730
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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-923A
• Device Lot Number: 6006078
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 09/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/16/2024
• 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 Age: 69 YR
• Patient Sex: Female