AUTOSOFT XC
Report
- Report Number
- 3003442380-2024-09368
- Event Type
- Injury
- Date Received
- June 22, 2024
- Date of Event
- May 23, 2024
- Report Date
- August 16, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
INITIAL AND FINAL MDR 1893416 - MDR 3003442380-2024-09368- DEVICE 1 OF 3.
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT ON (B)(6) 2024, PATIENT EXPERIENCED INFUSION SET CANNULA WAS KINKED. WITHIN 3 OR MORE HOURS OF ABDOMEN AND THE HIP AREA INSERTION CUSTOMER NOTICED SYMPTOMS. THE BLOOD GLUCOSE LEVEL OF THE PATIENT WAS 600 MG/DL. THEREFORE, THEY TRIED TO TREAT IT WITH CORRECTION BOLUS VIA PUMP AND MULTIPLE DAILY INJECTION. THE MULTIPLE EVENTS OCCURRED, FIRST HAPPENED ON (B)(6) 2024, SECOND ON (B)(6) 2024 AND THIRD ON 06 MAY 2024. ADDITIONALLY, THE PATIENT HAD MODERATE KETONES. ON (B)(6) 2024 PATIENT VISITED EMERGENCY ROOM FOR FEW HOURS AND TREATED WITH INTRAVENOUS (IV) AND FLUIDS OF SALINE AND INSULIN. UNOMEDICAL 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 WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1104235 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6000610 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Female | Required Intervention |