FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC,
MDR report key: 19677623
·
Received July 5, 2024
Report
- Report Number
- 3003442380-2024-11912
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- April 11, 2024
- Report Date
- July 3, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244026032
- 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 1903573 - MDR 3003442380-2024-11912 - DEVICE 2 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED THAT THE INFUSION SET CANNULA WAS KINKED WITHIN 3 OR MORE HOURS AFTER INSERTION AT BACK OF THE ARM. THE INFUSION SET WAS IN USE FOR 9 HOURS. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. 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 |
|---|---|---|---|---|---|---|---|
| 1133752 | AUTOSOFT XC, | INSET I 2-PACK 60/9 GREY TCAP | FPA | UNOMEDICAL A/S | 1010899 | UNKNOWN | 05705244026032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Male |