FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT XC
MDR report key: 19663636
·
Received July 3, 2024
Report
- Report Number
- 3003442380-2024-11698
- Event Type
- Malfunction
- Date Received
- July 3, 2024
- Date of Event
- May 6, 2024
- Report Date
- October 27, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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) - MDR DEVICE 1 OF 5.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). ON 06-MAY-2024, IT WAS REPORTED BY THE PATIENT THAT FIVE INFUSION SET CANNULA WAS LEAKING DUE TO WHICH HYPERGLYCEMIA OCCURS. HIGH BLOOD GLUCOSE LEVEL WAS 250 MG/DL. EVENT OCCURRED ON 05/06/2024, 05/08/2024, 05/17/2024, 05/22/2024, AND 05/24/2024. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 821761 | AUTOSOFT XC | UNO INSET I 60/6 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1001680 | 6004176 | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 24 YR | Male |