AUTOSOFT XC
Report
- Report Number
- 3003442380-2024-35236
- Event Type
- Injury
- Date Received
- December 31, 2024
- Date of Event
- November 13, 2024
- Report Date
- September 16, 2025
- Manufacturer
- UNOMEDICAL UM-D
- Product Code
- FPA
- UDI-DI
- 05705244022386
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INITIAL AND FINAL MDR 2082524 - MDR 3003442380-2024-35236 - DEVICE 2 OF 3.
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED INFUSION SET KINKED CANNULA EVENT ON (B)(6) 2024 AND (B)(6) 2024. THE EVENT THAT OCCURED ON (B)(6) 2024 WHICH LEADS TO HOSPITALIZATION AND EVENTUALLY WAS SHIFTED TO INTENSIVE CARE UNIT (ICU). THE EVENT OCCURRED THREE OR MORE HOURS AFTER INSERTION. THE INSERTION SITE WAS UPPER BUTTOCKS. THE INFUSION SET WAS IN USE FOR FEW HOURS. THE BLOOD GLUCOSE LEVEL WAS 560 MG/DL AT THE TIME OF EVENT AND THE PATIENT GOT TREATED WITH INTRAVENOUS FLUIDS OF SALINE AND INSULIN. PATIENT WAS FOUND POSITIVE FOR KETONES. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2024. COMPANY DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1847195 | AUTOSOFT XC | UNO INSET I 12/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL UM-D | 1006922 | 6007792 | 05705244022386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 14 YR | Female | Required Intervention| H |