FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19491840
·
Received June 7, 2024
Report
- Report Number
- 3003442380-2024-07192
- Event Type
- Malfunction
- Date Received
- June 7, 2024
- Date of Event
- April 29, 2024
- Report Date
- October 14, 2025
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018396
- PMA / PMN Number
- K061374
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1881957 - DEVICE 2 OF 6. PATIENT COUNTRY: UNITED STATES.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT PATIENT FACED AN ISSUE WITH SIX INFUSIONS SET CANNULAS WERE NOT INSERTED INTO BODY ALL THE WAY. THE ISSUE WAS NOTICED WITHIN 3 HOURS OF INSERTION. THE INSERTION SITE WAS ABDOMEN. THE BLOOD GLUCOSE LEVEL AT TIME OF EVENT WAS HIGH AND VALUED AS 300-445MG/DL. THE PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1031180 | AUTOSOFT 30 | UNO INSET 30 110/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002826 | 6001869 | 05705244018396 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Female |