BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19463406 · Received June 4, 2024

    Report

    Report Number
    2954323-2024-19339
    Event Type
    Injury
    Date Received
    June 4, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 4, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    35021791002659
    PMA / PMN Number
    K213996
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    APPLICATION/ SOFTWARE EXTENDED INVESTIGATION: 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 CUSTOMER EXPERIENCED A SENSOR ERROR MESSAGE WITH THE SENSOR IN USE WITH THE FREESTYLE LIBRE 3 APPLICATION. PRODUCT QUALITY ENGINEERING ATTEMPTED TO REPLICATE THE REPORTED ISSUE USING A CELLULAR DEVICE NOT IDENTICAL TO THE ACTUAL DEVICE, BUT WHICH SHARES RELEVANT CHARACTERISTICS WITH THE DEVICE INVOLVED AND [ANDROID (SAMSUNG GALAXY A52, ANDROID 13,3.5.1.10363), IOS (IPHONE 12, IOS 17.1.2,3.5.0.8863)] AND WAS NOT ABLE TO REPRODUCE THE COMPLAINT. THERE WERE NO ISSUES IDENTIFIED WITH THE FREESTYLE LIBRE 3 APP DURING REPLICATION THAT WOULD HAVE LED TO THE REPORTED ISSUE. SENSOR EXTENDED INVESTIGATION (NO PRODUCT RETURN): 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. 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.

    Description of Event or Problem · 0

    AN UNSPECIFIED ERROR MESSAGE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE AND CUSTOMER WAS UNABLE TO OBTAIN GLUCOSE READINGS. AS A RESULT, THE CUSTOMER BECAME HYPOGLYCEMIC AND HAD A SEIZURE. THE CUSTOMER WAS UNABLE TO SELF-TREAT AND WAS GIVEN GLUCOSE NOSE SPRAY BY A NON-HEALTHCARE PROFESSIONAL AND TABLETS FOR HEADACHE BY A HEALTHCARE PROFESSIONAL. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659065 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 35021791002659

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention