FDA Adverse Event
Malfunction
Summary report: N
FREESTYLE LIBRE 3
MDR report key: 23831017
·
Received December 17, 2025
Report
- Report Number
- MW5180735
- Event Type
- Malfunction
- Date Received
- December 17, 2025
- Report Date
- December 15, 2025
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QBJ
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TN, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
Description of Event or Problem · 0
REPORTER CALLED TO INFORM US THAT SHE RECEIVED A RECALL LETTER IN THE MAIL DATED (B)(6) 2025. SHE HAS BEEN HAVING SENSOR ISSUES SUCH AS INACCURATE LOW READINGS CAUSING THE PATIENT TO HAVE TO SWITCH TO FINGERSTICK TESTS. SENSORS ARE ALSO FAILING BEFORE 14 DAYS SHE REPORTED TO HAVE 5 DEFECTIVE SENSORS WITH THE SAME LOT NUMBER. PT CODE: 4582. DEVICE CODE: 1420. REF REPORTS: MW5180731, MW5180732, MW5180733, MW5180734.
Description of Event or Problem · 0
ADD'L INFO RECEIVED FOR REPORT MW5180735 ON 01/05/2026 TO UPDATE PROCODE TO QBJ.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2039680 | FREESTYLE LIBRE 3 | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED | QBJ | ABBOTT DIABETES CARE INC. | T60003596 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |