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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Hyperglycemia (1905)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to medtronic minimed that the customer reported change sensor.The customer experienced bleeding, hyperglycemia with blood glucose value of 500 mg/dl.The customer reported hyperglycemia was treated with pump.The event involved product(s) mmt-1884, mmt-342, mmt-431ag, mmt-7040a.Troubleshooting was performed for site issue and sensor issue.Troubleshooting was not performed for high blood glucose.It was unknown whether the customer was using the insulin pump system within 48 hours of reported event or not.It was unknown whether the customer was using the auto mode/smart guard feature at the time of the event or not.No further patient complications were reported.No product return is required for mmt-1884.No product return is required for mmt-342.No product return is required for mmt-431ag.No product return is required for mmt-7040a.
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.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.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; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: goutham pendyala ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 24740360
• Report Number: 2032227-2026-151800
• Device Sequence Number: 9835730
• Product Code: OZP
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 03/31/2026

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 Model Number: MMT-1884
• Device Catalogue Number: MMT-1884
• Device Lot Number: NG3731705H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 03/07/2024
• 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
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FRN-MMT-342-RSVR, UNOMED SET, OZP-MMT-7040A-SNSR.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 52 KG