FDA Adverse Event
Malfunction
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19736637
·
Received July 13, 2024
Report
- Report Number
- 3003442380-2024-13936
- Event Type
- Malfunction
- Date Received
- July 13, 2024
- Date of Event
- June 11, 2024
- Report Date
- July 13, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1911433 - MDR 3003442380-2024-13936 - DEVICE 1 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED 4 INFUSION SET FELL OFF EVENT ON (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 1-2 DAYS. THE GLUCOSE LEVEL WAS 200 MG/DL.. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 862283 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |