FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2024-37326
- Event Type
- Injury
- Date Received
- September 23, 2024
- Date of Event
- August 25, 2024
- Report Date
- November 24, 2024
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- PMA / PMN Number
- K193371
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- 003
Narratives
THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THIS SERVES AS A CORRECTION REPORT. SECTION(S) UPDATED AS FOLLOWS: D1 - BRAND NAME UPDATED TO FREESTYLE LIBRE 2 FROM FREESTYLE LIBRE 3. D2A - COMMON DEVICE NAME UPDATED TO FLASH GLUCOSE MONITORING SYSTEM FROM CONTINUOUS GLUCOSE MONITORING SYSTEM. D2B - PROCODE UPDATED TO QLG FROM QBJ. D4 - MODEL # UPDATED TO 71992-01 FROM 72081-01. THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION ACTIVITIES OR IF ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. 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. 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 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. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED AND 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. CLINICAL DATA WAS REVIEWED AND CONFIRMED THAT LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. THE AVAILABLE TRIPPED TREND REPORTS WERE REVIEWED FOR LIBRE SENSOR AND PERCEPTION CODE FOR THE LAST YEAR. THE REVIEW IDENTIFIED A TRIPPED TREND FOR THIS PERCEPTION CODE. THIS TRIPPED TREND WAS ADDRESSED IN THE TRACKING, TRENDING REVIEW MEETING, AND INVESTIGATED. THE INVESTIGATION CONCLUDED THAT THE TRIPPED TREND WAS NOT CORRELATED WITH PRODUCT NONCONFORMANCE. TRENDS ARE REGULARLY MONITORED AND INVESTIGATED WHEN EXCEEDING ESTABLISHED THRESHOLDS TO EVALUATE FOR CAUSES ASSOCIATED WITH THE PRODUCT. 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. UPON EXTENDED INVESTIGATION, IT WAS DETERMINED THAT THE SERIAL NUMBER PROVIDED BY THE CUSTOMER (3MH00Z96NYH) AND PREVIOUSLY REPORTED TO THE FDA WAS NOT A VALID SERIAL NUMBER. THEREFORE, SECTION D4 WAS UPDATED TO UNK. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
AN UNSPECIFIED ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED A LOSS CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO DIAGNOSED THE CUSTOMER WITH HYPOGLYCEMIA BUT NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN UNSPECIFIED ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED A LOSS CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO DIAGNOSED THE CUSTOMER WITH HYPOGLYCEMIA BUT NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
AN UNSPECIFIED ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. THE CUSTOMER EXPERIENCED A LOSS CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT. THE CUSTOMER HAD CONTACT WITH A HEALTHCARE PROFESSIONAL WHO DIAGNOSED THE CUSTOMER WITH HYPOGLYCEMIA BUT NO TREATMENT WAS REPORTED. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1487768 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71992-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |