MAUDE Adverse Event Report: Unomedical Devices S.A de C.V Comfort; Set, Administration, Intravascular

Model Number	MMT-377A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	06/22/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
To date, additional patient or event details were received which have been added in h11 (addl mfg narrative).
Event or Problem Description
It was reported that the patient experienced hyperglycemia of 316 mg/dl which treated with manual bolus via insulin pump, manual injection and insulin pen on (b)(6) 2026.
Additional Manufacturer Narrative
Imdrf investigation findings code: code c1902 is not available in database to capture device problem excluded.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 was conducted based on the event description and the assigned malfunction code no malfunction based on complaint information.Based on the available information, the event is consistent with misuse, user-related factors, or no malfunction alleged.In accordance with appendix of wi complaint handling, the need for additional investigation activities, including product testing, or electronic quality management system (eqms) search, was evaluated and determined not to be warranted for this record.However, as a lot number was provided and the event involved a serious injury, a batch record / medical device file review was conducted for lot 6016664 to assess any potential manufacturing-related issues.Batch record / medical device file review: the batch record / medical device file was reviewed.All required in-process and final tests were completed and met specified requirements.No deviations were identified, and no related maintenance activities were recorded.Conclusion: batch record / medical device file review supports compliance with manufacturing and quality requirements; no issues noted.Capa determination assessment, conclusion summary of complaint investigation: based on the investigation, no further investigation is required.The record will be closed and monitored through tracking and trending per work instruction (wi) (monthly trips and alerts).Complaint unconfirmed: following investigation, the reported failure could not be confirmed for this complaint.Fda registration number.Reporting site: 8021545.Manufacturing site: 3003442380.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury.To date no additional information has been received.Should additional information become available, a follow-up report will be submitted.Fda registration number.Reporting site: 8021545.Manufacturing site: 3003442380.

• Brand Name: Comfort
• Common Device Name: Set, Administration, Intravascular
• Manufacturer (Section D): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer (Section G): Unomedical Devices S.A de C.V; ave.fomento industrial l9 m3; parque industrial del norte; reynosa,tamps. 88736 ; MX 88736
• Manufacturer Contact: pamela meadows ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50022995
• Report Number: 3003442380-2026-57483
• Device Sequence Number: 18543527
• Product Code: FPA
• UDI-Device Identifier: 05705244019522
• UDI-Public: 05705244019522
• 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): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-377A
• Device Lot Number: 6016664
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2026
• Supplement Date Received by Manufacturer: 08/04/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/10/2025
• 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