FDA Adverse Event
Injury
Summary report: N
LIBRE 3 PLUS FREESTYLE
MDR report key: 24200031
·
Received January 28, 2026
Report
- Report Number
- MW5182947
- Event Type
- Injury
- Date Received
- January 28, 2026
- Date of Event
- December 17, 2025
- Report Date
- January 11, 2026
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QBJ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- WA, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
PLACED LIBRE 3 ON (B)(6) 2025. STARTED FEELING DISCOMFORT THE SAME DAY. TWO DAYS LATER HAD SWELLING ON AREA OF SENSOR (RIGHT UPPER ARM). NEXT DAY SWELLING INCLUDED THE ARM BETWEEN ELBOW AND SLIGHTLY ABOVE THE SENSOR. MEDICAL DOCTOR PLACED ME ON AUGMENTIN 500 MG. SWELLING STARTED GOING DOWN BUT STOPPED WHEN ANTIBIOTIC WAS FINISHED. 1.5 WEEKS LATER, MEDICAL DOCTOR PUT ME ON DOXYCYCLINE HYCLATE. SWELLING WENT DOWN MORE BUT STOPPED RESOLVING WHEN THE ANTIBIOTIC FINISHED. A SMALL AREA REMAINS SWOLLEN AND RED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 267525 | LIBRE 3 PLUS FREESTYLE | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED | QBJ | ABBOTT DIABETES CARE INC. | T60003720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 78 YR | Male | Required Intervention | AMLODIPINE.| CRESTOR. | ENBREL.| FOLIC ACID.| LISINOPRIL.| MULTIVITAMINS.| VITAMIN C.| VITAMIN D.| VITAMIN E. |