FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19591536
·
Received June 23, 2024
Report
- Report Number
- 3003442380-2024-09848
- Event Type
- Malfunction
- Date Received
- June 23, 2024
- Date of Event
- April 15, 2024
- Report Date
- June 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 1894504 - MDR 3003442380-2024-09848 - DEVICE 13 OF 16.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT PATIENT FACED SIXTEEN INFUSION SET FELL OFF EVENTS DURING USE. THE SETS WERE IN USE FOR 5-6 HOURS. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1019540 | 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 | 43 YR | Female |