FDA Adverse Event
Malfunction
Summary report: N
FREE STYLE LIBRE 3 SENSOR
MDR report key: 19875228
·
Received July 30, 2024
Report
- Report Number
- MW5157824
- Event Type
- Malfunction
- Date Received
- July 30, 2024
- Report Date
- July 26, 2024
- Manufacturer
- ABBOTT DIABETES CARE INC.
- Product Code
- QLG
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
- Health Professional
- *
Narratives
Description of Event or Problem · 0
FROM (B)(6) 2024 - (B)(6) 2024, I HAVE HAD 4 DEFECTED SENSORS. I CONTACTED ABBOTT AND SENT ALL 4 BACK AT DIFFERENT TIMES AND TO DATE HAVE NOT RECEIVED 4 REPLACEMENTS. THEREFORE I HAVE STOPPED USING THE SENSORS AND HAVE GONE BACK TO THE GLUCOSE MONITOR WITH FINGER STICKS. THIS IS DUE TO THE LACK OF COOPERATION FROM THE COMPANY. REFERENCE REPORT: MW5157821, MW5157822, MW5157823.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2075124 | FREE STYLE LIBRE 3 SENSOR | INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED | QLG | ABBOTT DIABETES CARE INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female |