FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19846753
·
Received July 27, 2024
Report
- Report Number
- 3003442380-2024-17358
- Event Type
- Malfunction
- Date Received
- July 27, 2024
- Date of Event
- May 21, 2024
- Report Date
- July 28, 2024
- 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 1924726 - MDR 3003442380-2024-17358 - DEVICE 4 OF 4
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED FOUR INFUSION SETS LEAKAGE EVENTS, LEAKAGE WAS LOCATED NEAR THE PLASTER PIECE WHERE IT MEETS THE ADHESIVE FOR ALL EVENTS. ALL THE EVENTS OCCURRED BETWEEN 21-MAY-2024 TO 28-MAY-2024. ALL THE SETS WERE IN USE FOR 24 HOURS AND THE PATIENT RESOLVED ALL THE EVENTS BY REPLACING INFUSION SETS AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 933657 | AUTOSOFT XC | INSET I 2-PACK 60/9 GREY TCAP | FPA | UNOMEDICAL A/S | 1010899 | 6000595 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male |