FDA Adverse Event
Malfunction
Summary report: N
MEDTRONIC EXTENDED
MDR report key: 19476269
·
Received June 6, 2024
Report
- Report Number
- 8021545-2024-00856
- Event Type
- Malfunction
- Date Received
- June 6, 2024
- Date of Event
- May 5, 2024
- Report Date
- June 6, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244023079
- PMA / PMN Number
- K210544
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1880314 - DEVICE 1 OF 2. E1: PATIENT CITY:(B)(6). PATIENT COUNTRY: UNITED STATES.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, THE PATIENT REPORTED THAT TWO INFUSION SET FELL OFF AND BG LEVEL IS LOW. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2244398 | MEDTRONIC EXTENDED | UNO EWIS BLUE 80/9 HCAP 1-PK INT | FPA | UNOMEDICAL A/S | MMT-442AJ | 6002089 | 05705244023079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |