MAUDE Adverse Event Report: Medtronic Puerto Rico Operations Co. MiniMed 780G OUS System BLE Connect 3.0 mmol/L; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1885
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	08/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to minimed that the customer experienced hypoglycemia.The customer also reported possible over delivery anomaly.Blood glucose value at the time of event was 3.4 mmol/l.The customer was treated with carb intake.The event involved product(s) mmt-1885.Troubleshooting was performed for hypoglycemia event.The customer was using the auto mode/smart guard feature at the time of the event.The customer was using the insulin pump system within 48 hours of reported event.No further patient complications were reported.The customer will discontinue the use of the device and revert to a backup plan per healthcare professional instructions.The product mmt-1885 will be returned for analysis.
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.Select patient information cannot be provided due to regional privacy regulations.The reported device is not marketed in the united states, but it is a same/similar device to one that is marketed inside the united states.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MiniMed 780G OUS System BLE Connect 3.0 mmol/L
• Common Device Name: AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL
• Manufacturer (Section D): Medtronic Puerto Rico Operations Co.; ceiba norte ind. park #50 road; juncos 00777 -386; PR 00777-3869
• Manufacturer (Section G): Medtronic Puerto Rico Operations Co.; ceiba norte ind. park #50 road; juncos 00777 -386; PR 00777-3869
• Manufacturer Contact: keya patel ; ceiba norte ind. park #50 road; juncos 00777--386 ; PR 00777-3869
• MDR Report Key: 50515466
• Report Number: 2032227-2026-230904
• Device Sequence Number: 13440843
• Product Code: OZP
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1885
• Device Catalogue Number: MMT-1885
• Device Lot Number: NG4253220H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2026
• Initial Report FDA Received Date: 08/31/2026
• Date Device Manufactured: 10/31/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Unknown