FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19583703
·
Received June 21, 2024
Report
- Report Number
- 3003442380-2024-09485
- Event Type
- Malfunction
- Date Received
- June 21, 2024
- Date of Event
- May 7, 2024
- Report Date
- June 21, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016712
- 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 1894416 - MDR 3003442380-2024-09485- DEVICE 2 OF 10.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED TWO INFUSION SETS FELL OFF DURING USE EVENTS BETWEEN 07-MAY-2024 AND 14-MAY-2024. THE INFUSION SET WAS IN USE FOR LESS THAN 12 HOURS. THE BLOOD GLUCOSE LEVEL WAS 150-200 MG/DL. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN DELIVERIES SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 221524 | AUTOSOFT XC | UNO INSET I 60/6 BLUE TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001683 | UNKNOWN | 05705244016712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Female |