FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19971415
·
Received August 13, 2024
Report
- Report Number
- 3003442380-2024-20966
- Event Type
- Malfunction
- Date Received
- August 13, 2024
- Date of Event
- June 1, 2024
- Report Date
- July 15, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018365
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR (B)(4).
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED SIX INFUSION SETS KINKED CANNULA WITHIN 3 HOURS OF INSERTION. SITE OF INSERTION WERE THIGH AND HIP. PATIENT'S BLOOD GLUCOSE AT THE TIME OF ISSUE WAS BETWEEN 200-438 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. 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 |
|---|---|---|---|---|---|---|---|
| 2484918 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | 6004623 | 05705244018365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Female |