FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19663953
·
Received July 3, 2024
Report
- Report Number
- 3003442380-2024-11778
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- April 19, 2024
- Report Date
- July 3, 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 (B)(4).- MDR DEVICE 1 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 19-APRIL-2024, IT WAS REPORTED BY THE PATIENT THAT INFUSION SET FELL OFF, FIRST ONE HAS BEEN RUBBED IN 48 HOURS AND THE SECOND ONE IS AT THE NIGHT AFTER 16 HOURS OF USE. EVENT OCCURRED ON 04/19/2924 AND 05/22/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 759325 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6003535 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR | Female |