FDA Adverse Event
Malfunction
Summary report: N
MINIMED MIO ADVANCE
MDR report key: 22553310
·
Received July 21, 2025
Report
- Report Number
- 8021545-2025-01850
- Event Type
- Malfunction
- Date Received
- July 21, 2025
- Date of Event
- June 20, 2025
- Report Date
- July 16, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018907
- PMA / PMN Number
- K173879
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
E1: PATIENT CITY: (B)(6). PATIENT COUNTRY: FRANCE.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN FRANCE. IT WAS REPORTED THAT THE PATIENT FACED AN INFUSION SET LEAKAGE EVENT ON (B)(6) 2025 AT CONNECTION WITH CATHETER/ RESERVOIR. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2731747 | MINIMED MIO ADVANCE | UNO MIO ADV. GREY 60/9 SC1 10-PK INT | FPA | UNOMEDICAL A/S | MMT-243A | 6011978 | 05705244018907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |