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	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	03/07/2026
Type of Reportable Event	Serious Injury
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.The device has been returned, but not yet evaluated.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.
Event or Problem Description
It was reported to medtronic minimed that the customer experienced hyperglycemia, and customer alleged pump is not releasing insulin.The customer reported blood glucose value of 500 mg/dl.The event involved products mmt-1884.Troubleshooting was not performed and it was unknown whether the customer had been using the insulin pump within 48 hours of the reported event, and unknown whether the auto mode feature was active at the time of the event.No further patient complications were reported.The customer will discontinue pump use and revert to back up plan as per health care professional instructions.The products mmt-1884 will be returned for analysis.
Additional Manufacturer Narrative
The pump passed the displacement test, rewind test, prime/seating test, basic occlusion test, and force sensor test.The pump passed the displacement accuracy test at 0.0875 inches.Test sc1 cap and reservoir locks properly into the reservoir compartment.Successfully downloaded pump history files and traces using thump and carelink software.Successfully generate carelink reports.Pump delivered 251 bolus deliveries on the event date of 07-mar-2026 at 00:03:01.000 to 23:53:21.000.No data for daily bolus total or basal total was found in the pump history files and traces.Pump was cut open to perform visual inspection and found no evidence of physical or moisture damage on the electronic assembly, motor, and force sensor.The following were also noted during visual inspection: scratched case and pillowing keypad overlay.Possible under delivery anomaly was not confirmed during testing.Unable to verify customer's complaint for high bg's.No device problem was noted during testing.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: 24738291
• Report Number: 2032227-2026-151450
• Device Sequence Number: 8843388
• Product Code: OZP
• UDI-Device Identifier: 000076300096003201
• UDI-Public: (01)000076300096003201(17)290119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/22/2026

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-1884
• Device Catalogue Number: MMT-1884
• Device Lot Number: NG4293039H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2026
• 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-UNK_RESERVOIR-RSVR, UNOMED INF SET
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR
• Patient Sex: Male