FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 90
MDR report key: 20107246
·
Received August 30, 2024
Report
- Report Number
- 3003442380-2024-23189
- Event Type
- Malfunction
- Date Received
- August 30, 2024
- Date of Event
- July 22, 2024
- Report Date
- November 25, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1954527- MDR 3003442380-2024-23189- DEVICE 1 OF 3.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 22-JUL-2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET TUBING WAS LEAKING AT THE SITE, WHICH CAUSE THE PATIENT BLOOD GLUCOSE LEVELS WAS ELEVATED TO HIGH, THEREFORE PATIENT HAD CHANGED SITE AND CARTRIDGE. THE INFUSION SET WAS IN USE FOR 2 DAYS. THE PATIENT REPLACED INFUSION SET/CARTRIDGE AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1802764 | AUTOSOFT 90 | UNO INSET II 60/9 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002824 | 6005496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Male |