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

Model Number	MMT-397
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was using expired infusion set that led to insulin flow block alarm and had high blood glucose levels of 324 mg/dl and was treated by correction bolus via pump on (b)(6)2025.
Additional Manufacturer Narrative
E1: patient city: (b)(6) patient country: united states.Unomedical hereby submits this initial report as part of its complaint remediation activities conducted under a capa 2356421 and capa 2566479 in accordance with the fda action plan, which incorporates (b)(4) (ic retrospective complaint review) and (b)(4)(ic retrospective mdr review).This submission includes a retrospective reassessment of previously evaluated complaints.Unomedical is providing this information in accordance with the reporting requirements set forth in 21 cfr part 803.Any fields left blank indicate that the information is unknown, unavailable, or remains unchanged.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: Quick Set
• 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: 50137581
• Report Number: 3003442380-2026-66104
• Device Sequence Number: 18770199
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K991759
• 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): 07/09/2026

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 Expiration Date: 03/17/2023
• Device Model Number: MMT-397
• Device Lot Number: 5313302
• 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: 07/09/2026
• Initial Report FDA Received Date: 08/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/17/2020
• 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