FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19808488
·
Received July 23, 2024
Report
- Report Number
- 3003442380-2024-15886
- Event Type
- Malfunction
- Date Received
- July 23, 2024
- Date of Event
- May 27, 2024
- Report Date
- November 8, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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 1919718 - MDR 3003442380-2024-15886- DEVICE 3 OF 3.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 27-MAY-2024, 28-MAY-2024 AND 10-JUN-2024 IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING DETACHED FROM CONNECTOR. THE INFUSION SET WAS IN USE FOR THREE HOURS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 964100 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003858 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Female |