MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. MINIMED 780G US SYSTEM BLE CONNECT 3.0 MG/DL; AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL

Model Number	MMT-1884
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Hyperglycemia (1905); Dizziness (2194); Elevated ketones/Diabetic Ketoacidosis (2364)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to medtronic minimed that the customer experienced hyperglycemia and diabetic ketoacidosis.The customer reported unable to hear the alerts from the pump.The customer reported blood glucose value of 533 mg/dl.The customer was hospitalized and treated with manual injection.The customer also experienced symptoms of dizzy.The event involved product(s) mmt-7040a, mmt-332a, mmt-1884, mmt-397a.Troubleshooting was performed.The customer was using the pump for 48 hour before the reported event.The customer was using the auto mode/smartguard feature at the time of the event.No further patient complications were reported.No product return is required for mmt-7040a, mmt-332a, mmt-397a.Mmt-1884 was requested and customer response was the device will be returned.The customer will discontinue using the device.
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.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 US SYSTEM BLE CONNECT 3.0 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• Manufacturer Contact: goutham pendyala ; ceiba norte ind. park #50 road; juncos 00777--386
• MDR Report Key: 24738602
• Report Number: 2032227-2026-151506
• Device Sequence Number: 8859259
• Product Code: OZP
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P160017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2026

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-1884
• Device Catalogue Number: MMT-1884
• Device Lot Number: NG4088986H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2026
• Supplement Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/04/2025
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-332A-RSVR, UNOMED INF SET; OZP-MMT-7040A-SNSR
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 106 KG