FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19662890
·
Received July 3, 2024
Report
- Report Number
- 3003442380-2024-11404
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- April 15, 2024
- Report Date
- July 1, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244014541
- 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 1900986 - MDR 3003442380-2024-11404 - DEVICE 3 OF 3.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET CANNULA KINKED EVENT ON (B)(6) 2024. THE SYMPTOMS APPEARED AFTER 3 HOURS OF INSERTION.THE SITE OF INSERTION WAS ABDOMEN. THE GLUCOSE LEVEL WAS IN BETWEEN 280 - 350 MG/DL. 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 AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821711 | AUTOSOFT 90 | INSET II 2-PACK 60/6 GREY TCAP | FPA | UNOMEDICAL A/S | 1000281 | UNKNOWN | 05705244014541 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |