MAUDE Adverse Event Report: Medtronic Puerto Rico Operations Co. Pump MMT-1886 780G OUS BLE Pump mg/dL; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1886
Medical Device Problem Code	Unauthorized Access to Computer System (3025)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to minimed that the customer experienced hypoglycemia.The customer also reported cybersecurity hacking allegation.Blood glucose value at the time of event was 30 mg/dl.The customer was treated with glucose/carb intake and emergency room visit.The event involved product(s) mmt-1886.Troubleshooting was performed.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.Customer was able to upload and complete carelink.Advised the pump will need to be replaced.No further patient complications were reported.The customer will discontinue use of the insulin pump.Mmt-1886 was requested and the customer response was that the device will be returned.
Additional Manufacturer Narrative
This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the 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 device to one that is marketed inside the united states.\ \ minimed submits this report to comply with fda regulations 21 cfr parts 4 and 803.Minimed 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, minimed , or its employees that the device, minimed , 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.Minimed will submit a supplemental report if additional relevant information becomes known.

• Brand Name: Pump MMT-1886 780G OUS BLE Pump mg/dL
• 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: 51170747
• Report Number: 2032227-2026-259196
• Device Sequence Number: 21790116
• Product Code: OZP
• UDI-Device Identifier: 000076300063927301
• UDI-Public: (01)000076300063927301
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: Exempt
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/22/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-1886
• Device Catalogue Number: MMT-1886
• Device Lot Number: NG3698928H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 10/22/2026
• Date Device Manufactured: 01/18/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRN-UNK_RESERVOIR-Rsvr, Unomed Set; SFI-MMT-5120C1-Snsr
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 24 YR
• Patient Sex: Unknown