BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19235099 · Received May 2, 2024

    Report

    Report Number
    2954323-2024-15141
    Event Type
    Injury
    Date Received
    May 2, 2024
    Date of Event
    April 20, 2024
    Report Date
    June 13, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    35021791003724
    PMA / PMN Number
    K213996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE SOFTWARE/DATA CORRUPTION OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. 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. THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE FREESTYLE LIBRE 3 APP COMPLAINT WAS INVESTIGATED AND DETERMINED THAT THERE WERE NO ISSUES WITH THE FREESTYLE LIBRE 3 APPLICATION THAT WOULD HAVE LED TO THE COMPLAINT. THE USER REPORTED REPLACE SENSOR MESSAGE. ATTEMPTED TO REPLICATE THE USER¿S COMPLAINT USING SIMILAR CONFIGURATION AND THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED AND THE SYSTEM FUNCTIONED AS INTENDED. SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION PERFORMED ON THE RETURNED SENSOR PATCH AND NO ISSUE WAS OBSERVED. DATA WAS EXTRACTED USING APPROVED SOFTWARE, AND EXTRACTION WAS SUCCESSFUL. THE RETURNED SENSOR WAS FURTHER INVESTIGATED AND DE-CASED. PERFORMED AN INTERNAL VISUAL INSPECTION ON THE SENSOR¿S PCBA (PRINTED CIRCUIT BOARD ASSEMBLY); NO ISSUES WERE OBSERVED. PERFORMED AN SMU (SOURCE MEASUREMENT UNIT) TEST TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY, AND THE RETURNED UNIT DID NOT HAVE ANY GLUCOSE READING ISSUES. POISE VOLTAGE TESTING WAS WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THEREFORE THIS ISSUE IS NOT CONFIRMED. THIS ALSO SERVES AS A CORRECTION REPORT. SECTION H11 (ADDITIONAL MFG NARRATIVE) WAS INCORRECTLY DOCUMENTED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING, CONVULSIONS/SEIZURE, AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS TREATED BY A NON-HEALTHCARE PROFESSIONAL WHO PROVIDED A GLUCAGON HYPO-KIT INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A "REPLACE SENSOR" ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) IN USE WITH SAMSUNG GALAXY A32, OS- 13, APP VERSION- 3.5.1.10.363 DEVICE AND THE CUSTOMER WAS UNABLE TO OBTAIN READINGS. AS A RESULT, THE CUSTOMER EXPERIENCED SWEATING, CONVULSIONS/SEIZURE, AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER WAS TREATED BY A NON-HEALTHCARE PROFESSIONAL WHO PROVIDED A GLUCAGON HYPO-KIT INJECTION. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437761 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 35021791003724

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention