FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFTÂ 30
MDR report key: 19848465
·
Received July 28, 2024
Report
- Report Number
- 3003442380-2024-17632
- Event Type
- Malfunction
- Date Received
- July 28, 2024
- Date of Event
- June 19, 2024
- Report Date
- December 10, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1925058 - MDR 3003442380-2024-17632 - DEVICE 2 OF 3
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN CANADA. IT WAS REPORTED THAT PATIENT FACED 3 INFUSION SET TUBE LEAKAGE AT SITE EVENT ON (B)(6)2024. INFUSION SET HAS BEEN USED FOR 8 HOURS. BLOOD GLUCOSE LEVEL WAS 19MMOL/L. CUSTOMER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1776537 | AUTOSOFTÂ 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | 6004380 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Male |