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

Model Number	MMT-378A
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	08/13/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient does not change site as per ifu and experienced hyperglycemia, blood glucose 403 mg/dl treated with insulin pump on (b)(6) 2026.
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be 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: armando cuello ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; +1(603)247-0255
• MDR Report Key: 50823001
• Report Number: 3003442380-2026-010102
• Device Sequence Number: 10648691
• Product Code: FPA
• UDI-Device Identifier: 05705244019553
• UDI-Public: 05705244019553
• 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
• Report Date (Section B): 08/19/2026

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-378A
• Device Lot Number: 6016901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2026
• 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