FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19814729
·
Received July 24, 2024
Report
- Report Number
- 3003442380-2024-16092
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- June 5, 2024
- Report Date
- July 23, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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 1920003 -MDR 3003442380-2024-16092 DEVICE 1 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 05-JUNE-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WERE KINKED WITHIN 3 HOURS OF INSERTION AT ABDOMEN, WHICH CAUSE THE PATIENT BLOOD GLUCOSE ELEVATED TO 440 MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN 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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2366352 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6000700 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female |