BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINKUP

    MDR report key: 19605595 · Received June 25, 2024

    Report

    Report Number
    2954323-2024-22250
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    February 20, 2024
    Report Date
    July 5, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    PJT
    UDI-DI
    00357599824006
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    EXTENDED INVESTIGATION IS PENDING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE DEVICE MANUFACTURING DATE DOES NOT APPLY. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    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. 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. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT. THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. THE USER REPORTED MISSING HIGH AND LOW ALARM. THE REPORTED ISSUE WAS INVESTIGATED AND ATTEMPTED TO REPLICATE. THE REPORTED CONFIGURATION WAS NOT COMPATIBLE WITH THE CUSTOMER'S REPORTED APPLICATION. THE LATEST REVISION OF THE COMPATIBILITY GUIDE WAS AVAILABLE TO THE CUSTOMER ON THE ABBOTT DIABETES CARE WEBSITE. 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 ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION 17.2.1. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "SCREAMING, SLEEPING", A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER RECEIVED TREATMENT OF HONEY, SUGAR AND GLUCAGON INJECTION PROVIDED BY A NON-HEALTHCARE PROFESSIONAL (CAREGIVER). THE CAREGIVER REPORTED CALLING EMERGENCY SERVICES BUT IT IS UNKNOWN IF THEY ADMINISTERED ANY ADDITIONAL MEDICAL TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH IPHONE PHONE WITH IOS OPERATING SYSTEM VERSION 17.2.1 AND APP VERSION 2.11.2.8275. THE LOW AND HIGH GLUCOSE ALARMS DID NOT SOUND AND CUSTOMER WAS NOT ALERTED OF CHANGES IN GLUCOSE LEVEL. AS A RESULT, THE CUSTOMER EXPERIENCED "SCREAMING, SLEEPING", A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER RECEIVED TREATMENT OF HONEY, SUGAR AND GLUCAGON INJECTION PROVIDED BY A NON-HEALTHCARE PROFESSIONAL (CAREGIVER). THE CAREGIVER REPORTED CALLING EMERGENCY SERVICES BUT IT IS UNKNOWN IF THEY ADMINISTERED ANY ADDITIONAL MEDICAL TREATMENT. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723034 FREESTYLE LIBRELINKUP FREESTYLE LIBRE LINKUP PJT ABBOTT DIABETES CARE LTD 72154-01 00357599824006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention