FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19826147
·
Received July 25, 2024
Report
- Report Number
- 3003442380-2024-16566
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 10, 2024
- Report Date
- July 25, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018426
- 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 1921256 - MDR 3003442380-2024-16566 - DEVICE 3 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS FELL OFF EVENTS DURING USE ON DATE (B)(6) 2024. THE INFUSION SET WAS IN USE FOR 48 HOURS. BLOOD GLUCOSE LEVEL WAS 170 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2482451 | TRUSTEEL | UNO CONTACT DETACH G29 60/6 TCAP | FPA | UNOMEDICAL A/S | 1002833 | 6004904 | 05705244018426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Female |