AUTOSOFT XC
Report
- Report Number
- 3003442380-2024-06367
- Event Type
- Malfunction
- Date Received
- June 6, 2024
- Date of Event
- April 22, 2024
- Report Date
- June 6, 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
INITIAL AND FINAL MDR 1880828 - DEVICE 2 OF 3
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. THE PATIENT REPORTED ISSUES WITH 3 INFUSION SETS, ALL OF THE SAME TYPE. THE CANNULA OF THE INFUSION SET WAS BENT. THE EVENT DATES WERE RECORDED AS 22-APR-20224 FOR 2 EVENTS AND 29-APR-2024. FOR ANOTHER EVENT. THE PATIENT NOTICED SYMPTOMS WITHIN 3 HOURS OF INSERTION, AND THE SITE OF INSERTION WAS THE ABDOMEN. THE PATIENT REGULARLY ROTATES THE SITE LOCATION, AND THE SITE AREA WAS NOT IMPACTED IN ANY WAY. THE PATIENT CONFIRMED THAT THE INTRODUCER NEEDLE WAS AHEAD OF THE CANNULA PRIOR TO INSERTION. THE PATIENT'S BLOOD GLUCOSE (BG) WAS HIGH AND TOOK A CORRECTION INJECTION VIA MDI TO ADDRESS THE HIGH BG. THE PATIENT RESOLVED THE ISSUE BY REPLACING THE INFUSION SET AND SUCCESSFULLY RESUMED INSULIN DELIVERIES. 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 |
|---|---|---|---|---|---|---|---|
| 2055511 | AUTOSOFT XC | INSET I 2-PACK 60/9 GREY TCAP | FPA | UNOMEDICAL A/S | 1010899 | UNKNOWN | 05705244026032 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Male |