FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19826210
·
Received July 25, 2024
Report
- Report Number
- 3003442380-2024-16567
- 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 3003442380-2024-16567 - DEVICE 4 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 10-JUNE-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 |
|---|---|---|---|---|---|---|---|
| 354374 | 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 |