FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19525342
·
Received June 12, 2024
Report
- Report Number
- 3003442380-2024-07726
- Event Type
- Malfunction
- Date Received
- June 12, 2024
- Date of Event
- April 23, 2024
- Report Date
- June 12, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018181
- 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 1885101 - MDR 3003442380-2024-07726 - DEVICE 3 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 23-APR-2024,IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SET FELL OFF DURING USE EVENTS. THE INFUSION SET HAD BEEN USED FOR 2 HOURS. THE PATIENT REPLACED THE INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1184161 | AUTOSOFT 90 | UNO INSET II 60/9 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002819 | UNKNOWN | 05705244018181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Male |