FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19842568
·
Received July 26, 2024
Report
- Report Number
- 3003442380-2024-16837
- Event Type
- Malfunction
- Date Received
- July 26, 2024
- Date of Event
- June 17, 2024
- Report Date
- July 26, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K041545
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1922589 - MDR 3003442380-2024-16837- DEVICE 9 OF 10.E1: PATIENT COUNTRY: UNITED KINGDOM.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED KINGDOM. IT WAS REPORTED THAT PATIENT FACED TEN INFUSION SETS FELL OFF EVENTS DURING DOING USE ON DATE 17-JUNE-2024. THE INFUSION SET WAS IN USE FOR SOME HOURS. PATIENT BG LEVEL FOUND TO BE HIGH. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459761 | TRUSTEEL | INFUSION DEVICES - UNKNOWN | FPA | UNOMEDICAL A/S | INFUSION DEVICES - UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |