FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 20093971
·
Received August 29, 2024
Report
- Report Number
- 3003442380-2024-22962
- Event Type
- Malfunction
- Date Received
- August 29, 2024
- Date of Event
- July 24, 2024
- Report Date
- November 11, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1953644- MDR 3003442380-2024-22962- DEVICE 3 OF 14.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT FACED LEAKAGE OF TUBING AT SITE. THE ISSUE OCCURRED WITH FOURTEEN TYPES OF INFUSION SETS USED FOR TEN MINUTES. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 376 MG/DL. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1158889 | AUTOSOFT XC | UNO INSET I 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001681 | 6003280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Female |