FDA Adverse Event
Malfunction
Summary report: N
TRUSTEEL
MDR report key: 19558127
·
Received June 18, 2024
Report
- Report Number
- 3003442380-2024-08821
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- April 19, 2024
- Report Date
- June 19, 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 1890567- MDR 3003442380-2024-08821- DEVICE 4 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED BY THE PATIENT THAT SIX INFUSIONS SET FELL OFF DUE TO WHICH HYPERGLYCEMIA OCCURS WITHIN ONE DAYS OF USE. HIGH BLOOD GLUCOSE LEVEL WAS 270 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2315597 | TRUSTEEL | UNO CONTACT DETACH G29 60/6TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002833 | UNKNOWN | 05705244018426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |