FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19814736
·
Received July 24, 2024
Report
- Report Number
- 3003442380-2024-16193
- Event Type
- Malfunction
- Date Received
- July 24, 2024
- Date of Event
- June 9, 2024
- Report Date
- July 23, 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 1920015 -MDR 3003442380-2024-16193 DEVICE 3 OF .
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 09-JUNE-2024, 11-JUNE-2024, 12-JUNE-2024 AND 14-JUNE-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET FELL OFF DURING USE. THE INFUSION SET WAS IN USE FOR 15 TO 18 HOURS ON AVERAGE. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2366359 | 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 | 46 YR | Male |