FDA Adverse Event
Injury
Summary report: N
INFUSION DEVICES - UNKNOWN
MDR report key: 19788906
·
Received July 21, 2024
Report
- Report Number
- 3003442380-2024-15750
- Event Type
- Injury
- Date Received
- July 21, 2024
- Date of Event
- June 18, 2024
- Report Date
- January 26, 2026
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
(B)(4).
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN AUSTRALIA. IT WAS REPORTED THAT PATIENT FACED INFUSION SET OCCLUSION EVENT ON 18-JUN-2024. DUE TO HIGH BLOOD GLUCOSE LEVEL AS WELL AS KETONE LED UP TO HOSPITALIZATION OF PATIENT.. THE BLOOD GLUCOSE LEVEL WAS OVER 19MMOL/L. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2480891 | INFUSION DEVICES - UNKNOWN | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |