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

Model Number	MMT-396A
Medical Device Problem Codes	Complete Blockage (1094); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information, this event is deemed to be a reportable 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 name medtronic minimed street 18000 devonshire street city northridge state ca zip code 91325 zip four 1219 u.S.
Event or Problem Description
It was reported on 16-mar-2026 that the infusion set cannula was bent, which elevated the glucose level to 285 mg/dl and was treated with a correction bolus via pump.

• 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: courtney smith ; aaholmvej 1 - 3; osted; lejre 4320 ; DA 4320 ; 6032470255
• MDR Report Key: 24887886
• Report Number: 3003442380-2026-83355
• Device Sequence Number: 21306585
• Product Code: FPA
• UDI-Device Identifier: 05705244024960
• UDI-Public: 05705244024960
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• 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): 03/18/2026

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
• Device Model Number: MMT-396A
• Device Lot Number: 6013820
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2025
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown