FDA Adverse Event
Malfunction
Summary report: N
UNO INSET I 60/6 GREY TCAP 10PK INT
MDR report key: 19558346
·
Received June 18, 2024
Report
- Report Number
- 3003442380-2024-08828
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- April 19, 2024
- Report Date
- June 18, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244016620
- 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 1890695 - MDR 3003442380-2024-08827- DEVICE 2 OF 2.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT TWO INFUSION SET CANNULAS WERE KINKED WHICH LED TO HIGH BLOOD GLUCOSE LEVEL. THE SITE OF INSERTION WSS ABDOMEN. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2262636 | UNO INSET I 60/6 GREY TCAP 10PK INT | AUTOSOFT XC | FPA | UNOMEDICAL A/S | 1001680 | UNKNOWN | 05705244016620 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male |