FDA Adverse Event
Malfunction
Summary report: N
AUTOSOFT 30
MDR report key: 19431792
·
Received May 30, 2024
Report
- Report Number
- 3003442380-2024-04684
- Event Type
- Malfunction
- Date Received
- May 30, 2024
- Date of Event
- March 8, 2024
- Report Date
- May 30, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- 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 1875024 - MDR 3003442380-2024-04684 - DEVICE 3 OF 4.
Description of Event or Problem · 0
UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, THE PATIENT REPORTED THAT 4 INFUSION SET CANNULA WAS BENT, WITHIN 3 HOURS OF INSERTION THE SITE OF INSERTION IS ABDOMEN AND THIGH. THE BLOOD GLUCOSE LEVEL GOES UPTO 200 MG/DL. 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 |
|---|---|---|---|---|---|---|---|
| 307883 | AUTOSOFT 30 | UNO INSET 30 60/13 GREY TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002825 | 6001611 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Male |