FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19525345
·
Received June 12, 2024
Report
- Report Number
- 3003442380-2024-07649
- 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. DEVICE 1 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 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 |
|---|---|---|---|---|---|---|---|
| 1184164 | 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 |