BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 3

    MDR report key: 19269798 · Received May 8, 2024

    Report

    Report Number
    2954323-2024-15963
    Event Type
    Injury
    Date Received
    May 8, 2024
    Date of Event
    April 9, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    QLJ
    UDI-DI
    30357599818006
    PMA / PMN Number
    K212132
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    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. 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 SENSOR KIT EXPIRATION DATE IS 29-FEB-2024. THE MEDICAL EVENT ASSOCIATED WITH THIS CASE OCCURRED ON 10-APR-2024 WHICH CONFIRMS THE USAGE OF THE DEVICE BEYOND THE USEFUL LIFE OF THE DEVICE. NO ADDITIONAL INVESTIGATION ARE REQUIRED AS THE DEVICE MET ITS SPECIFICATION LIFESPAN. 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

    A HIGH GLUCOSE READINGS ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. THE CUSTOMER RECEIVED A HIGH READING OF 300 MG/DL ON THE ADC DEVICE AND AN HOUR LATER, A FINGERSTICK RESULT OF 156 MG/DL WAS OBTAINED ON AN UNSPECIFIED DEVICE. THE CUSTOMER EXPERIENCED LOSS OF CONSCIOUSNESS AND WAS SEEN AT A HOSPITAL WHERE THEY WERE HOSPITALIZED AND RECEIVED UNSPECIFIED MEDICAL TREATMENT FOR THE REPORTED ISSUE. DURING TROUBLESHOOTING, IT WAS CONFIRMED THAT THE CUSTOMER WAS USING AN EXPIRED SENSOR BUT NO FURTHER INFORMATION WAS OBTAINED AS THE REPORTER REFUSED TO PROVIDE ANY ADDITIONAL AND HUNG UP THEIR CALL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758978 FREESTYLE LIBRE 3 CONTINUOUS GLUCOSE MONITORING SYSTEM QLJ ABBOTT DIABETES CARE LTD 72081-01 30357599818006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention