FDA Adverse Event
Malfunction
Summary report: N
LIBRE 3 PLUS
MDR report key: 23780234
·
Received December 11, 2025
Report
- Report Number
- MW5180355
- Event Type
- Malfunction
- Date Received
- December 11, 2025
- Date of Event
- November 2, 2025
- Report Date
- December 7, 2025
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QBJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- NC, US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
ADDITIONAL INFORMATION RECEIVED ON 12/15/2025 FOR REPORT MW5180355 TO UPDATE PROCODE TO QBJ.
Description of Event or Problem · 0
GAVE A LOW SUGAR ALARM. NOTICE OF DEFECTIONS WITH LIBRE 3 PLUS THESE ARE MINE THAT I CURRENTLY HAVE. I AM WEARING ONE OF THE 5. PT CODE: 4582. DEVICE CODE: 2460. REFERENCING REPORTS: MW5180353, MW5180354, MW5180356, AND MW5180357.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2696256 | LIBRE 3 PLUS | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED | QBJ | ABBOTT DIABETES CARE INC. | T60003536 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Male | Other |