FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2025-23875
- Event Type
- Injury
- Date Received
- June 26, 2025
- Date of Event
- June 6, 2025
- Report Date
- August 28, 2025
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- UDI-DI
- 04987439092928
- PMA / PMN Number
- K193371
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
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. THE DATE OF EVENT IS UNKNOWN. THE DATE ENTERED IN SECTION B3 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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 INCIDENT ARE THE ADHESIVE, INCLUDING THE ADHESIVE IRRITATING THE USER¿S SKIN, OR MISUSE, INCLUDING IMPROPER SITE SELECTION AND REPEATEDLY USING THE SAME APPLICATION SITE TO PLACE THE SENSOR. THESE CONDITIONS ARE MITIGATED THROUGH THE FREESTYLE PRODUCT LABELLING. 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 PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR KITS. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR KITS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC MINIMUM REQUIREMENTS FOR PRODUCT QUALITY. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR KIT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. IF PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
SENSOR (B)(6) WAS RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR PATCH AND ADHESIVE AND NO ISSUES WERE OBSERVED. NO MALFUNCTION OR PRODUCT DEFICIENCY WAS IDENTIFIED. THIS ISSUE IS NOT CONFIRMED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT IS RELATED TO SKIN IRRITATION OR AN ALLERGIC REACTION TO THE PATCH ADHESIVE OF THE FREESTYLE LIBRE SENSOR. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATES THE CONTINUED EFFECTIVENESS OF THE ESTABLISHED STERILIZATION PROCESS FOR LIBRE SENSOR KITS. ENVIRONMENTAL MONITORING REPORTS WERE REVIEWED, INCLUDING BIOBURDEN AND ENDOTOXIN TESTING, AND DEMONSTRATED THAT ALL MONITORING PROCESSES CONTINUE TO MEET ADC MINIMUM REQUIREMENTS FOR PRODUCT QUALITY. DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR KIT WAS REVIEWED AND THE DHRS SHOWED THE LIBRE SENSOR KIT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. SECTION D4 (PRIMARY UDI NUMBER), D4 (EXPIRATION DATE) AND H4 (DEVICE MFG DATE) WERE UPDATED BASED ON RETURNED PRODUCT DOWNLOAD. SECTION D4 (SERIAL NUMBER) WAS UPDATED FROM (B)(6) TO (B)(6). THIS ALSO SERVES AS A CORRECTION REPORT. SECTION E1 (COUNTRY) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED BLEEDING WHEN THE SENSOR WAS ATTACHED. IN ADDITION, THE CUSTOMER REPORTS THAT THE AREA AT THE SENSOR INSERTION SITE BECAME SWOLLEN AND "HARD". THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PRESCRIBED PROPET (SKIN PROTECTANT) MIXED WITH BETAMETHASONE BUTYRATE PROPIONATE OINTMENT 0.05% "MYK" AND OLOPATADINE HYDROCHLORIDE OD TABLET 5MG "VTRS" FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED BLEEDING WHEN THE SENSOR WAS ATTACHED. IN ADDITION, THE CUSTOMER REPORTS THAT THE AREA AT THE SENSOR INSERTION SITE BECAME SWOLLEN AND "HARD". THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PRESCRIBED PROPET (SKIN PROTECTANT) MIXED WITH BETAMETHASONE BUTYRATE PROPIONATE OINTMENT 0.05% "MYK" AND OLOPATADINE HYDROCHLORIDE OD TABLET 5MG "VTRS" FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER EXPERIENCED BLEEDING WHEN THE SENSOR WAS ATTACHED. IN ADDITION, THE CUSTOMER REPORTS THAT THE AREA AT THE SENSOR INSERTION SITE BECAME SWOLLEN AND "HARD". THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO PRESCRIBED PROPET (SKIN PROTECTANT) MIXED WITH BETAMETHASONE BUTYRATE PROPIONATE OINTMENT 0.05% "MYK" AND OLOPATADINE HYDROCHLORIDE OD TABLET 5MG "VTRS" FOR TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1175537 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71992-01 | 04987439092928 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |