FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 19585258
·
Received June 21, 2024
Report
- Report Number
- 3003442380-2024-09590
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Date of Event
- May 17, 2024
- Report Date
- June 21, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018303
- 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 1892698 - MDR 3003442380-2024-09590 - DEVICE 2 OF 4
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN ITALY 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 LESS THAN 3 DAYS. THE PATIENT REPLACED INFUSION SETS AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221623 | AUTOSOFT 90 | UNO INSET II 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002823 | 5408136 | 05705244018303 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |