FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19571147
·
Received June 19, 2024
Report
- Report Number
- 3003442380-2024-09031
- Event Type
- Malfunction
- Date Received
- June 19, 2024
- Date of Event
- April 13, 2024
- Report Date
- October 29, 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 1891593 - MDR 3003442380-2024-09031 - DEVICE 9 OF 10.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES IT WAS REPORTED THAT PATIENT FACED EXTREME DIFFICULTIES GETTING THE SPRING TO PULL BACK WITH TEN INFUSION SETS SINCE (B)(6) 2024. BLOOD GLUCOSE LEVELS WERE 385 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1511878 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003735 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Female |