FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19889798
·
Received August 1, 2024
Report
- Report Number
- 3003442380-2024-18624
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- June 1, 2024
- Report Date
- July 3, 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 (B)(4).
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON 01-JUNE-2024, IT WAS REPORTED BY THE PATIENT THAT FIVE INFUSION SETS FELL OFF DURING USE EVENTS ON 15-APRIL-2024, 15-APRIL-2024, 25-MAY-2024, 01-JUNE-2024, AND 10-JUNE-2024. INFUSION SET WAS IN USE FOR A COUPLE HOURS TO 2 DAYS. THE PATIENT REPLACED THE INFUSION SET AND INSULIN WAS RESUMED SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 984848 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6004729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Female |