FDA Adverse Event
Malfunction
Summary report: N
VARISOFT
MDR report key: 19990476
·
Received August 15, 2024
Report
- Report Number
- 8021545-2024-03305
- Event Type
- Malfunction
- Date Received
- August 15, 2024
- Date of Event
- June 26, 2024
- Report Date
- July 17, 2024
- Manufacturer
- UNOMEDICAL A/S
- Product Code
- FPA
- UDI-DI
- 05705244018723
- PMA / PMN Number
- K162812
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
INITIAL AND FINAL MDR 1942223- MDR 8021545-2024- 03305- DEVICE 1 OF 2.
Description of Event or Problem · 0
REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. IT WAS REPORTED THAT THE PATIENT EXPERIENCED CANNULA ISSUES WITH TWO INFUSION SETS. THE CANNULAS WERE CRIMPED. THE EVENT OCCURRED ON (B)(6) 2024 AND (B)(6) 2024. PATIENT NOTICED SYMPTOMS WITHIN 3 OR MORE HOURS OF INSERTION. THE INSERTION OF SITE WAS THE ABDOMEN. PATIENT REGULARLY ROTATED SITE LOCATION. BLOOD GLUCOSE LEVEL WAS BETWEEN 70-180 MG/DL AT THE TIME OF THE EVENT. PATIENT REPLACED INFUSION SET AND RESUMED INSULIN SUCCESSFULLY. NO FURTHER INFORMATION WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1094336 | VARISOFT | UNO COMFORT SHORT 80/13 TCAP 10PK INT | FPA | UNOMEDICAL A/S | 1002828 | 05705244018723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Male |