FREESTYLE LIBRE 2 PLUS
Report
- Report Number
- 2954323-2026-52777
- Event Type
- Injury
- Date Received
- April 29, 2026
- Date of Event
- April 4, 2026
- Report Date
- April 28, 2026
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QBJ
- UDI-DI
- 05021791006946
- PMA / PMN Number
- K223435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
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 MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. 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 6 (INDICATING EARLY TERMINATION). SENSOR STATE 6 WITH EVENT LOGS 6 AND 7 ARE AN INDICATION THAT THE PATCH WAS TERMINATED WITHOUT ANY ERROR. THE EVENT LOGS OBSERVED ARE CONSISTENT WITH NORMAL TERMINATION AND INDICATE THE SENSOR HAS REACHED ITS END OF LIFE. ACCEPTABLE DEBRIS ON PCBA (PRINTED CIRCUIT BOARD ASSEMBLY) TRIANGLE WAS OBSERVED. ALSO, ACCEPTABLE ADDITIONAL CARBON PRINT WAS OBSERVED. VISUAL INSPECTION HAS BEEN PERFORMED ON THE SENSOR PLUG ASSEMBLY, NO FAILURE MODES WERE OBSERVED. PERFORMED AN SMU (SOURCE MEASUREMENT UNIT) TEST TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY, AND THE RETURNED UNIT DID NOT HAVE ANY GLUCOSE READING ISSUES. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THE PASSING OF FUNCTIONALITY TESTING IS AN INDICATION THAT THERE WERE NO ISSUES WITH SENSOR FUNCTIONALITY AND ELECTRONICS, THEREFORE THIS ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A "SCAN AGAIN IN 10 MINUTES" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS TREMORS, WEAKNESS, COULDN'T SPEAK AND SELF-TREATED WITH A SUGAR PACKET. SUBSEQUENTLY, THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE THEY HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO OBTAINED A READING OF 412 MG/DL ON AN HCP METER AND ADMINISTERED AN UNSPECIFIED INTRAVENOUS DRIP FOR HYDRATION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A "SCAN AGAIN IN 10 MINUTES" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS TREMORS, WEAKNESS, COULDN'T SPEAK AND SELF-TREATED WITH A SUGAR PACKET. SUBSEQUENTLY, THE CUSTOMER WAS TAKEN TO THE HOSPITAL WHERE THEY HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO OBTAINED A READING OF 412 MG/DL ON AN HCP METER AND ADMINISTERED AN UNSPECIFIED INTRAVENOUS DRIP FOR HYDRATION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349111 | FREESTYLE LIBRE 2 PLUS | CONTINUOUS GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE INC | 78747-01 | 05021791006946 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |