FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19677347
·
Received July 4, 2024
Report
- Report Number
- 3003442380-2024-11621
- Event Type
- Malfunction
- Date Received
- July 4, 2024
- Date of Event
- March 1, 2024
- Report Date
- July 4, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1902028- MDR 3003442380-2024- 11621- DEVICE 2 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. EVENT OCCURED ON (B)(6) 2024. IT WAS REPORTED BY THE PATIENT THAT 5 INFUSION SET FELL OFF WITHIN 24 HOURS OF USE. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1132743 | 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 | 37 YR | Female |