FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2025-44870
- Event Type
- Death
- Date Received
- November 14, 2025
- Date of Event
- October 23, 2025
- Report Date
- November 19, 2025
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QBJ
- PMA / PMN Number
- K223435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE; HOWEVER, AT THIS TIME PRODUCT HAS NOT YET BEEN RECEIVED. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS 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. 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. A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE AVAILABLE TRACKING AND TRENDING REPORTS WERE CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. 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.
ABBOTT DIABETES CARE (ADC) RECEIVED AN ANSM REPORT, WHICH REPORTED THE FOLLOWING INFORMATION: A LAY USER AND A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT ON THE NIGHT OF (B)(6) 2025. THE CUSTOMER WAS EQUIPPED WITH A YPSOPUMP/CAMAPS FX SEMI-CLOSED-LOOP SYSTEM PAIRED WITH A FREESTYLE LIBRE 3 SENSOR. IT WAS INDICATED THAT THE CUSTOMER WAS FOUND ON THE FLOOR BY THEIR SPOUSE EXHIBITING SIGNS OF VOMITING. THE CUSTOMER WAS ALERTED OF HYPOGLYCEMIA AND TREATED WITH 103 GRAMS OF CARBOHYDRATES, FOLLOWED BY 3.4-UNIT BOLUS OF (UNSPECIFIED INSULIN). IT WAS REPORTED THAT THERE WERE NUMEROUS SUBSEQUENT ALARMS THAT INDICATED PERSISTENT SEVERE HYPOGLYCEMIA. ADDITIONALLY, IN AUGUST, THERE WAS A REPORT OF "A CONNECTION PROBLEM BETWEEN THE PUMP AND THE TELEPHONE, REQUIRING THE APPLICATION TO BE UNINSTALLED AND THEN REINSTALLED," AS WELL AS A FAULTY SENSOR. THE CUSTOMER'S SPOUSE INFORMED THE LAY USER AND HCP THAT THE CUSTOMER DIED ON THE NIGHT OF (B)(6) 2025. ON 11 NOVEMBER 2025, ADC CUSTOMER SERVICE CONTACTED THE HCP WHO STATED THAT THE MEDICAL EVENT IS NOT RELATED TO THE ADC DEVICE AS IT ¿DETECTED THE HYPOS AND THE ALARMS WERE WORKING.¿ NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. ADC CUSTOMER SERVICE IS CURRENTLY IN THE PROCESS OF MAKING ADDITIONAL ATTEMPTS TO GAIN FURTHER INFORMATION, AND A FOLLOW-UP WILL BE SUBMITTED WHEN MORE INFORMATION IS OBTAINED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT IS INCONCLUSIVE WHETHER THE ADC DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH.
ABBOTT DIABETES CARE (ADC) RECEIVED AN ANSM REPORT, WHICH REPORTED THE FOLLOWING INFORMATION: A LAY USER AND A HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT A CUSTOMER EXPERIENCED A HYPOGLYCEMIC EVENT ON THE NIGHT OF (B)(6) 2025. THE CUSTOMER WAS EQUIPPED WITH A YPSOPUMP/CAMAPS FX SEMI-CLOSED-LOOP SYSTEM PAIRED WITH A FREESTYLE LIBRE 3 SENSOR. IT WAS INDICATED THAT THE CUSTOMER WAS FOUND ON THE FLOOR BY THEIR SPOUSE EXHIBITING SIGNS OF VOMITING. THE CUSTOMER WAS ALERTED OF HYPOGLYCEMIA AND TREATED WITH 103 GRAMS OF CARBOHYDRATES, FOLLOWED BY 3.4-UNIT BOLUS OF (UNSPECIFIED INSULIN). IT WAS REPORTED THAT THERE WERE NUMEROUS SUBSEQUENT ALARMS THAT INDICATED PERSISTENT SEVERE HYPOGLYCEMIA. ADDITIONALLY, IN AUGUST, THERE WAS A REPORT OF "A CONNECTION PROBLEM BETWEEN THE PUMP AND THE TELEPHONE, REQUIRING THE APPLICATION TO BE UNINSTALLED AND THEN REINSTALLED," AS WELL AS A FAULTY SENSOR. THE CUSTOMER'S SPOUSE INFORMED THE LAY USER AND HCP THAT THE CUSTOMER DIED ON THE NIGHT OF (B)(6) 2025.ON 11 NOVEMBER 2025, ADC CUSTOMER SERVICE CONTACTED THE HCP WHO STATED THAT THE MEDICAL EVENT IS NOT RELATED TO THE ADC DEVICE AS IT ¿DETECTED THE HYPOS AND THE ALARMS WERE WORKING.¿ NO FURTHER INFORMATION HAS BEEN RECEIVED AT THIS TIME. ADC CUSTOMER SERVICE IS CURRENTLY IN THE PROCESS OF MAKING ADDITIONAL ATTEMPTS TO GAIN FURTHER INFORMATION, AND A FOLLOW-UP WILL BE SUBMITTED WHEN MORE INFORMATION IS OBTAINED. BASED ON THE INFORMATION CURRENTLY AVAILABLE, IT IS INCONCLUSIVE WHETHER THE ADC DEVICE HAS OR MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2851399 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE LTD | 72081-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |