FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19718409
·
Received July 11, 2024
Report
- Report Number
- 3003442380-2024-13387
- Event Type
- Malfunction
- Date Received
- July 11, 2024
- Date of Event
- January 1, 2024
- Report Date
- July 11, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016712
- 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 (B)(4) - DEVICE 12 OF 15.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FIFTEEN INFUSION SETS FELL OFF DURING USE ON 01 JAN 2024. THE INFUSION SET WAS IN USE FOR THREE DAYS. THE BG LEVEL WAS NOTICED 180-216 MG/DL. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2379589 | AUTOSOFT XC | UNO INSET I 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001683 | UNKNOWN | 05705244016712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 19 YR | Female |