FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2025-37835
- Event Type
- Injury
- Date Received
- September 22, 2025
- Date of Event
- August 13, 2025
- Report Date
- October 23, 2025
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QBJ
- UDI-DI
- 05021791002658
- PMA / PMN Number
- K223435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
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.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; HOWEVER, AT THIS TIME PRODUCT HAS NOT YET BEEN RECEIVED. 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. DHRS (DEVICE HISTORY REVIEW) FOR THE PRODUCT WAS REVIEWED AND THE DHRS SHOWED THE PRODUCT MET SPECIFICATIONS PRIOR TO RELEASE TO DISTRIBUTION. DOSE AUDIT REPORTS WERE REVIEWED AND DEMONSTRATED 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 REQUIREMENTS. 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. 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.
AN ADVERSE SKIN REACTION WAS REPORTED WITH WEAR OF THE ABBOTT DIABETES CARE (ADC) DEVICE. CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS SKIN INFECTION AT THE SENSOR SITE AND HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO PRESCRIBED AMOXICLAV 875/125 INTRAVENOUSLY THREE TIMES PER DAY FOR TREATMENT. THE CUSTOMER WAS HOSPITALIZED FROM (B)(6) 2025. 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. CUSTOMER EXPERIENCED SYMPTOMS DESCRIBED AS SKIN INFECTION AT THE SENSOR SITE AND HAD CONTACT WITH A HEALTHCARE PROFESSIONAL (HCP) WHO PRESCRIBED AMOXICLAV 875/125 INTRAVENOUSLY THREE TIMES PER DAY FOR TREATMENT. THE CUSTOMER WAS HOSPITALIZED FROM (B)(6)2025 TO (B)(6)2025. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1960801 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE LTD | 72081-01 | 05021791002658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Hospitalization| R |