FREESTYLE LIBRE 2 PLUS
Report
- Report Number
- 2954323-2025-29317
- Event Type
- Injury
- Date Received
- July 28, 2025
- Date of Event
- June 13, 2025
- Report Date
- September 16, 2025
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QBJ
- PMA / PMN Number
- K223435
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- 003
Narratives
PHYSICAL INVESTIGATION OF PRODUCT IS NOT ANTICIPATED AS REPORTER INDICATED DEVICE WAS DISCARDED. INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES, AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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. 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. 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 IS IN PROGRESS. NO CORRECTIVE ACTIONS HAVE BEEN TAKEN AT THIS TIME. 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 HAVE LEAD TO THE COMPLAINT. THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. THEREFORE, NO FURTHER INVESTIGATION IS PLANNED. 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.
A LOW GLUCOSE READINGS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED AN UNSPECIFIED LOWER GLUCOSE SENSOR SCAN RESULTS COMPARED TO UNSPECIFIED GLUCOSE READINGS OBTAINED ON A COMPETITOR BRAND DEVICE AND NOTED A DIAGONAL DOWNWARDS TREND ARROW WHICH INDICATES GLUCOSE IS FALLING (BETWEEN 1 AND 2 MG/DL PER MINUTE). THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS TAKEN TO A HOSPITAL WHERE THEY WERE TREATED WITH "LEV'S PRO 30-UNIT HMP0" AND 34-50 UNITS OF LONG "SHIVA" INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
A LOW GLUCOSE READINGS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED AN UNSPECIFIED LOWER GLUCOSE SENSOR SCAN RESULTS COMPARED TO UNSPECIFIED GLUCOSE READINGS OBTAINED ON A COMPETITOR BRAND DEVICE AND NOTED A DIAGONAL DOWNWARDS TREND ARROW WHICH INDICATES GLUCOSE IS FALLING (BETWEEN 1 AND 2 MG/DL PER MINUTE). THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS TAKEN TO A HOSPITAL WHERE THEY WERE TREATED WITH "LEV'S PRO 30-UNIT HMP0" AND 34-50 UNITS OF LONG "SHIVA" INSULIN. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610143 | FREESTYLE LIBRE 2 PLUS | FLASH GLUCOSE MONITORING SYSTEM | QBJ | ABBOTT DIABETES CARE INC | 78747-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |