FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19749137
·
Received July 16, 2024
Report
- Report Number
- 3003442380-2024-14688
- Event Type
- Malfunction
- Date Received
- July 16, 2024
- Date of Event
- June 8, 2024
- Report Date
- July 17, 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 1913875 - MDR 3003442380-2024-14688 - DEVICE 2 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SET CANNULA KINKED EVENTS ON (B)(6) 2024. EVENT OCCURRED WITHIN THREE HOURS OF INSERTION SITE WAS AT ABDOMEN. BLOOD GLUCOSE LEVELS WERE 280-290 MG/DL AT THE TIME OF EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2507005 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | UNKNOWN | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Male |