FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19825977
·
Received July 25, 2024
Report
- Report Number
- 3003442380-2024-16491
- Event Type
- Malfunction
- Date Received
- July 25, 2024
- Date of Event
- June 4, 2024
- Report Date
- July 25, 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 (B)(4). MDR DEVICE 3 OF 3.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 4-JUNE-2024, IT WAS REPORTED THAT PATIENT FACED THREE INFUSION SETS FELL OFF EVENTS DURING USE ON 06/04/2024, 06/07/2024, 06/14/2024. THE INFUSION SET WAS IN USE FOR 30 HOURS. PATIENT BLOOD GLUCOSE LEVEL WAS FOUND TO BE 204 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 357503 | 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 | 9 YR | Female |