MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MINIMED SILHOUETTE; UNO COMFORT 110/17 SC1 MINI

Model Number	MMT-377A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2025
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 insulin flow blocked alarm event on (b)(6) 2025.The blockage was in the tubing connector.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: revision 21 of (b)(4) does not require a complaint that is type 2 reportable to open a child investigation.This child investigation was opened against a previous revision of (b)(4).Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003364, in question was manufactured at the reynosa site.Threshold analysis: a query was run on 22-sep-2025 against "final reporting decision equal "serious injury" and "death", "lot number" criteria equal "6003364".The count of complaint is 0 which is below 3.No further statistical trending analysis is required.Device history record (dhr) review: the lot 6003364 was manufactured according to the work instruction (wi) version 15 and manufactured in the machine multivac 10 on 20/sep/2023, with a total of (b)(4) units.Glue-tubing lot: the lot 3j01361 was manufactured according to the (wi) version 10 and manufactured in the machine lc02 on 12/sep/2023, with a total of (b)(4) units.Review of the device history record (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 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: MINIMED SILHOUETTE
• Common Device Name: UNO COMFORT 110/17 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: 21750046
• Report Number: 3003442380-2025-05102
• Device Sequence Number: 9658529
• Product Code: FPA
• UDI-Device Identifier: 05705244019522
• UDI-Public: 05705244019522
• Combination Product (Y/N): Y
• 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): 09/23/2025

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: 08/19/2026
• Device Model Number: MMT-377A
• Device Lot Number: 6003364
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Supplement Date Received by Manufacturer: 09/23/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/20/2023
• 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