FREESTYLE LIBRE 2 PLUS
Report
- Report Number
- 2954323-2025-40021
- Event Type
- Malfunction
- Date Received
- October 8, 2025
- Date of Event
- September 28, 2025
- Report Date
- April 10, 2026
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QBJ
- UDI-DI
- 00357599871000
- PMA / PMN Number
- K223435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED ON THE SENSOR PATCH. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). SENSOR STATE 5 WITH EVENT LOGS 3 AND 4 ARE AN INDICATION OF NORMAL TERMINATION OF THE SENSOR WITHOUT ANY ERROR. VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY, NO FAILURE MODES WERE OBSERVED. CIG ATTEMPTED TO REPROGRAM THE RETURNED PATCH, HOWEVER AN ERROR OCCURRED DURING REPROGRAMMING. THIS ERROR PREVENTED THE RETURNED PATCH FROM BEING REPROGRAMMED AND THEREFORE, CIG WAS UNABLE TO TEST THIS ISSUE. FURTHER INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION HAS BEEN PERFORMED AND NO ISSUES OBSERVED. THE SENSOR EVENT LOG WAS UNABLE TO BE EXTRACTED AND ALSO UNABLE TO REPROGRAMED THE SENSOR THROUGH THE PATCH PROGRAMMER. BENCH TESTING WAS PERFORMED ON THE RETURNED SENSOR. THE RETURNED SENSOR WAS PLACED ON THE EVM (EVALUATION MODULE) AND WAS VERIFIED TO BE UNABLE TO SCAN WITH THE OBSERVED ERROR MESSAGE DEVICE NOT COMPATIBLE. DUE TO THE INABILITY OF THE SENSOR TO SCAN OR BE REPROGRAMMED, FURTHER FUNCTIONALITY TESTING WAS UNABLE TO BE PERFORMED. THE ISSUE OF THE SENSOR EXHIBITING LOW GLUCOSE READINGS WAS UNABLE TO TEST DUE TO THE RETURNED SENSOR BEING UNABLE TO SCAN, WHICH WAS AN INDICATION OF DATA CORRUPTION TO THE SENSOR. SECTION H6 (INVESTIGATION FINDINGS) CODE C20 (NO FINDINGS AVAILABLE) AND D15 CAUSE NOT ESTABLISHED WAS SELECTED, AS ADC WAS UNABLE TO PERFORM FURTHER TESTING ON THE RETURNED DEVICE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/ DEFICIENCY. IF A PRODUCT DEFECT/ DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/ RISK RATIO. AT THIS TIME, THE PRODUCT HAS NOT YET BEEN RETURNED FOR THIS COMPLAINT. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR AND SENSOR KIT MEET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT WILL BE SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 77 MG/DL COMPARED TO READINGS OF 200 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 12 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE CUSTOMER RECEIVED SENSOR SCAN RESULTS OF 77 MG/DL COMPARED TO READINGS OF 200 MG/DL RESPECTIVELY OBTAINED ON A METER AND THE RESULTS, WHEN PLOTTED ON A PARKES ERROR GRID, FALL INTO THE C ZONE, SHOWING THE DIFFERENCE IN VALUES TO BE CLINICALLY SIGNIFICANT. THE LENGTH OF SENSOR WEAR WAS 12 DAYS. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2513225 | FREESTYLE LIBRE 2 PLUS | FLASH GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE INC | 78747-01 | 00357599871000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |