BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 20076581 · Received August 27, 2024

    Report

    Report Number
    2954323-2024-32717
    Event Type
    Injury
    Date Received
    August 27, 2024
    Date of Event
    July 28, 2024
    Report Date
    August 27, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    PMA / PMN Number
    K212132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR INVESTIGATION AND THE CUSTOMER AGREED TO RETURN THE DEVICE, HOWEVER, AT THIS TIME PRODUCT HAS NOT YET BEEN RECEIVED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. AN 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 FREESTYLE LIBRE SENSORS CONTINUE TO BE SAFE, EFFECTIVE, AND PERFORM AS INTENDED IN THE FIELD. STABILITY DATA FOR FREESTYLE LIBRE SENSORS WAS REVIEWED AND SHOWED NO ANOMALIES OR NON-CONFORMANCES THAT COULD HAVE LED TO THE COMPLAINT. THE AVAILABLE TRIPPED TREND REPORTS WERE REVIEWED FOR LIBRE SENSOR AND READ-21 FOR THE LAST YEAR. THE REVIEW IDENTIFIED A TRIPPED TREND FOR THIS PERCEPTION CODE. THIS TRIPPED TREND WAS ADDRESSED IN THE TRACKING AND TRENDING REVIEW PROCESS. THE REVIEW CONCLUDED THAT THE TRIPPED TREND WAS NOT CORRELATED WITH ANY IDENTIFIED PRODUCT RELATED ISSUE. 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. IF PRODUCT IS RETURNED, 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.

    Description of Event or Problem · 0

    A LOW GLUCOSE READINGS ISSUE WITH THE ABBOTT DIABETES CARE (ADC) DEVICE WAS REPORTED. THE CUSTOMER RECEIVED AN UNSPECIFIED LOW GLUCOSE SCAN ON THE ADC DEVICE COMPARED TO AN UNKNOWN BLOOD GLUCOSE TEST RESULT OBTAINED FROM AN COMPETITOR DEVICE. THE CUSTOMER NOTED A HORIZONTAL TREND ARROW WHICH INDICATES GLUCOSE IS CHANGING SLOWLY (LESS THAN 1 MG/DL PER MINUTE). THE CUSTOMER EXPERIENCED SYMPTOMS OF DIZZINESS AND THEN EXPERIENCED A LOSS OF CONSCIOUSNESS. THE CUSTOMER RECOVERED FROM THE LOSS OF CONSCIOUSNESS ON THEIR OWN WITHOUT THIRD PARTY ASSISTANCE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19240 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Unknown Other