FREESTYLE LIBRE 3 PLUS
Report
- Report Number
- 2954323-2025-47538
- Event Type
- Death
- Date Received
- December 8, 2025
- Date of Event
- October 23, 2025
- Report Date
- January 14, 2026
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QBJ
- PMA / PMN Number
- K223435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
THIS REPORT SERVES AS FOLLOW UP AS ADDITIONAL INFORMATION HAS BEEN OBTAINED BY CUSTOMER SERVICE. THE FOLLOWING FIELDS HAVE BEEN UPDATED: B5: UPDATED NARRATIVE H6: ANNEX E CODE UPDATED TO E120501. H6: ANNEX E CODE UPDATED TO A090808. THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS THE RELATIVE DECLINED TO RETURN THE DEVICE AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. ADC¿S INVESTIGATION OF THE REPORTED COMPLAINT HAS BEEN COMPLETED AND DETERMINED THAT THERE WAS NO INDICATION THAT THE FREESTYLE LIBRE 3 PLUS DEVICE DID NOT MEET SPECIFICATION. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD LEAD TO THE COMPLAINT. TRACKING AND TRENDING REPORTS FOR THE PAST YEAR WERE REVIEWED BASED ON THE PRODUCT LINE AND REPORTED ISSUE. THE REVIEW IDENTIFIED A TRIPPED TREND, AND AN INVESTIGATION WAS CONDUCTED, AND CORRECTIVE ACTIONS HAVE BEEN TAKEN. 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. IN THE EVENT THAT THE DEVICE IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. 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.
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. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT FREESTYLE LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD LEAD TO THE COMPLAINT. 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. IN THE EVENT THAT PRODUCT IS RECEIVED, 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.
ON (B)(6) 2025, ADC RECEIVED ADDITIONAL INFORMATION VIA EMAIL FROM THE RELATIVE IN RESPONSE TO FOLLOW UP QUESTIONS REGARDING THE REPORTED EVENT. THE CUSTOMER¿S RELATIVE RESPONDED REPORTING A LOW READINGS ISSUE AND THAT THE MEDICAL EVENT OCCURRED ON AN UNKNOWN DAY OF SENSOR WEAR. THE LOW READINGS WERE PRECEDED BY NAUSEA, VOMITING, AND POLYURIA. WHEN PARAMEDICS ARRIVED, THE FREESTYLE LIBRE DEVICE DISPLAYED 2.9 MMOL/L, WHILE A COMPARATIVE BLOOD GLUCOSE MEASUREMENT WAS REPORTED ¿NO LONGER MEASURABLE". THE TYPE OF COMPARATIVE BLOOD GLUCOSE METER USED IS UNKNOWN, AND NO HISTORICAL COMPARISON DATA COULD BE RETRIEVED BY THE RELATIVE. THE CUSTOMER REMAINED IN INTENSIVE CARE FROM JULY 9 TO (B)(6) 2025 WITH TREATMENT DETAILS BEING UNKNOWN AND REPORTED MEDICAL DIAGNOSIS OF KETOACIDOSIS. THE ALLEGED DATE OF DEATH WAS (B)(6) 2025. A DEATH CERTIFICATE HAS NOT BEEN PROVIDED TO ADC AT THIS TIME. BASED ON THE RELATIVE¿S REPORT, THE CAUSE OF DEATH WAS DESCRIBED AS ¿DIABETIC SHOCK DUE TO FREESTYLE LIBRE AND INCORRECT METER READINGS¿. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT CANNOT BE REASONABLY CONCLUDED THAT THE FREESTYLE LIBRE 3 PLUS DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH.
AN UNSPECIFIED READINGS ISSUE WAS REPORTED WITH USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE. IT WAS REPORTED THE CUSTOMER ALLEGEDLY RECEIVED UNSPECIFIED HIGHER AND LOWER GLUCOSE SCANS. IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND IT WAS REPORTED THAT THE CUSTOMER WAS SEEN AT THE HOSPITAL WHERE A HEALTHCARE PROFESSIONAL TOOK UNSPECIFIED LABORATORY READINGS FOR A DIAGNOSIS OF HYPERGLYCEMIA AND EVENTUALLY DEATH. NO AUTOPSY REPORT OR DEATH CERTIFICATE HAS BEEN PROVIDED AT THIS TIME. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE ADC DEVICE HAS LED TO OR CONTRIBUTED TO THE REPORTED DEATH.
AN UNSPECIFIED READINGS ISSUE WAS REPORTED WITH USE OF THE ABBOTT DIABETES CARE (ADC) DEVICE. IT WAS REPORTED THE CUSTOMER ALLEGEDLY RECEIVED UNSPECIFIED HIGHER AND LOWER GLUCOSE SCANS. IT IS UNKNOWN WHETHER THE CUSTOMER NOTED A TREND ARROW ON THE DEVICE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND IT WAS REPORTED THAT THE CUSTOMER WAS SEEN AT THE HOSPITAL WHERE A HEALTHCARE PROFESSIONAL TOOK UNSPECIFIED LABORATORY READINGS FOR A DIAGNOSIS OF HYPERGLYCEMIA AND EVENTUALLY DEATH. NO AUTOPSY REPORT OR DEATH CERTIFICATE HAS BEEN PROVIDED AT THIS TIME. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE ADC DEVICE HAS LED TO OR CONTRIBUTED TO THE REPORTED DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1738504 | FREESTYLE LIBRE 3 PLUS | CONTINUOS GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE INC | 78768-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |