FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19591539
·
Received June 23, 2024
Report
- Report Number
- 3003442380-2024-09845
- 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 -DEVICE 10 OF 16
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 15-APR-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 |
|---|---|---|---|---|---|---|---|
| 1183405 | 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 |