FDA Adverse Event
Malfunction
Summary report: N
UNO INSET II 60/9 BLUE TCAP 10PK INT
MDR report key: 19558380
·
Received June 18, 2024
Report
- Report Number
- 3003442380-2024-08915
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- April 4, 2024
- Report Date
- June 18, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018334
- PMA / PMN Number
- K032854
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1890728 - MDR 3003442380-2024-08915 - DEVICE 3 OF 6.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN UNITED STATES. IT WAS REPORTED THAT INFUSION SET TUBING WAS LEAKING AT SITE CONNECTOR AREA WHICH LED TO HIGH BG. THE INFUSION SET WAS IN USE FOR 1.5 DAYS. CUSTOMER PERFORMED CORRECTION BOLUS VIA PUMP AND CORRECTION INJECTION VIA MDI. CALLER REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1613862 | UNO INSET II 60/9 BLUE TCAP 10PK INT | AUTOSOFT 90 | FPA | UNOMEDICAL A/S | 1002824 | UNKNOWN | 05705244018334 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 20 YR | Female |