MAUDE MDR 50941442
- MDR report key
- 50941442
- Report number
- 2032227-2026-246722
- Event key
- 0
- Event type
- 3
- Date of event
- 2025-12-19
- Date received
- 2026-09-30
- Adverse event
- 0
- Product problem
- 1
- Patients in event
- 0
- Reporter occupation
- 3
- Health professional
- 0
- Initial report to FDA
- 0
- Event location
- 0
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 319553 | MiniMed 780G OUS System BLE Connect 3.0 mmol/L | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | Medtronic Puerto Rico Operations Co. | OZP | MMT-1885 | MMT-1885 | NG3913786H | | | | | N |
| 418195 | MiniMed 780G OUS System BLE Connect 3.0 mmol/L | AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL | Medtronic Puerto Rico Operations Co. | OZP | MMT-1885 | MMT-1885 | NG3913786H | | | | | N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2026-09-30 | 0 | |
Event Narratives#
No narrative records found.