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

Model Number	MMT-943A
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/03/2025
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 at the site.The insertion site was abdomen.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted common device name under d2, model number, serial number, primary unique device identifier (udi) number under d4.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 6010071, in question was manufactured at the reynosa site.Device history record (dhr) review: the lot 6010071 was manufactured according to the work instruction (wi) version 74 in the line 05, on 01/nov/2024, with a total of (b)(4) units review of the dhr showed that during the outgoing test 6 an extended was found for contamination in three sample and therefore 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: INSET
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 23422130
• Report Number: 3003442380-2025-15537
• Device Sequence Number: 12832278
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K032854
• 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-943A
• Device Lot Number: 6010071
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/30/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2024
• 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: 19 YR
• Patient Sex: Female