FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19677893
·
Received July 5, 2024
Report
- Report Number
- 3003442380-2024-12139
- Event Type
- Malfunction
- Date Received
- July 5, 2024
- Date of Event
- March 28, 2024
- Report Date
- July 6, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016712
- PMA / PMN Number
- K032854
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1905003 -MDR 3003442380-2024-12139 DEVICE 1 OF 3.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. EVENT OCCURED ON (B)(6) 2024, IT WAS REPORTED THAT THREE INFUSION SET WAS FELL OFF DURING USE. PATIENT'S BLOOD GLUCOSE AT TIME OF EVENT IS UNKNOWN. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 901695 | AUTOSOFT XC | INUNO INSET I 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001683 | UNKNOWN | 05705244016712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Female |