MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. COMFORT; UNO COMFORT 80/17 SC1 MINI

Model Number	MMT-384A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that the patient faced infusion set detachment event on (b)(6) 2025 while sleeping.The site of detachment was at quick release.The infusion set was in use for two days.The site location was arm.The blood glucose level was high and the patient was treated with insulin pump.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.Complaint investigation results: a complaint investigation has been initiated to review the device history record (dhr) associated with the reported issue.The batch 6005826, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6005826 was manufactured according to the work instruction (wi) version 17 in the machine multivac m10, on 04/mar/2024, with a total of (b)(4) units.The sub-assembly: cannula.The lot 4b04395 was manufactured according to the form version 14 and manufactured in the machine lc04, on 28-feb-2024, with a total of (b)(4) units.The lot 4b06209 was manufactured according to the form version 14 and manufactured in the machine lc04, on 02-mar-24, with a total of (b)(4) units.The lot 3m01081 was manufactured according to the form version 14 and manufactured in the machine lc04, on 13-dic-2023, with a total of (b)(4) units.The sub-assembly: gluing of tubing.The lot 4b04394 was manufactured according to the form version 14 and manufactured in the machine lc01, on 27-feb-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 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: COMFORT
• Common Device Name: UNO COMFORT 80/17 SC1 MINI
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23529314
• Report Number: 3003442380-2025-16196
• Device Sequence Number: 15708436
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K162812
• 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 Model Number: MMT-384A
• Device Lot Number: 6005826
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 11/11/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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