FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 20536235
·
Received October 25, 2024
Report
- Report Number
- 3003442380-2024-29310
- Event Type
- Malfunction
- Date Received
- October 25, 2024
- Date of Event
- August 28, 2024
- Report Date
- November 3, 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 2020574 - MDR 3003442380-2024-29310 - DEVICE 10 OF 12.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED TWELVE EVENTS OF INFUSION SET TUBING DETACHED FROM CONNECTOR ON (B)(6) 2024. THE INFUSION SETS HAD BEEN USED FOR TWO DAYS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1568844 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 5408298 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Female |