FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19673989
·
Received July 4, 2024
Report
- Report Number
- 3003442380-2024-11552
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- June 1, 2024
- Report Date
- July 4, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016651
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1902037 - MDR 3003442380-2024-11552 -DEVICE 2 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATE. THE PATIENT HAVE REPORTED THAT THE INFUSION SET FELL OFF 4 TIMES DURING USE ON (B)(6) 2024. IT WAS CONFIRMED THAT THE INFUSION SET WAS IN USE FOR 12 HOURS, 12 HOURS, 2 HOURS, 2 HOURS RESPECTIVELY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573060 | AUTOSOFT XC | UNO INSET / 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001681 | 6003990 | 05705244016651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Female |