| Brand Name | MiniMed 780G US System BLE Connect 3.0 mg/dL |
| Common Device Name | Alternate Controller Enabled Insulin Infusion Pump |
| 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 | 50204214 |
| Report Number | 2032227-2026-220290 |
| Device Sequence Number | 13105253 |
| Product Code |
QFG
|
| Combination Product (Y/N) | N |
| Initial Reporter State | CO |
| 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) |
08/31/2026 |
| 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-1884 |
| Device Catalogue Number | MMT-1884 |
| Device Lot Number | NG3750830H |
| Was Device Available for Evaluation? |
Yes
|
| Date Returned to Manufacturer | 08/17/2026 |
| Is the Reporter a Health Professional? |
No
|
| Type of Report(Section G) | Thirty-Day |
| Initial Date Received by Manufacturer | 08/02/2026 |
| Supplement Date Received by Manufacturer | 08/18/2026
|
| Initial Report FDA Received Date | 08/31/2026 |
| Supplement Report FDA Received Date | 08/31/2026
|
| Was Device Evaluated by Manufacturer? (Y/N) |
Yes
|
| Date Device Manufactured | 04/05/2024 |
| 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 |
| Patient Age | 62 YR |
| Patient Sex | Male |
| Patient Weight | 165 LB |