MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A DE C.V COMFORT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MMT-384A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced high blood glucose on 18-mar-2026 and high blood glucose level was treated with pump.
Additional Manufacturer Narrative
Name: medtronic minimed country: united states of america street: (b)(6) city: (b)(6) state: (b)(6) zip code: (b)(6) based on the available information, this event is deemed to be a reportable malfunction.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:(b)(4) manufacturing site: (b)(4).

• 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: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24921069
• Report Number: 3003442380-2026-81978
• Device Sequence Number: 10671580
• Product Code: FPA
• UDI-Device Identifier: 05705244019676
• UDI-Public: 05705244019676
• Combination Product (Y/N): N
• 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: Foreign,Consumer,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: Other
• Device Expiration Date: 07/28/2026
• Device Model Number: MMT-384A
• Device Lot Number: 6002982
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 04/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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