BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINKUP

    MDR report key: 19570435 · Received June 19, 2024

    Report

    Report Number
    2954323-2024-21502
    Event Type
    Injury
    Date Received
    June 19, 2024
    Date of Event
    October 13, 2023
    Report Date
    August 5, 2024
    Manufacturer
    ABBOTT DIABETES CARE LTD
    Product Code
    PJT
    UDI-DI
    00357599824006
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    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

    THE REPORTED COMPLAINT WAS INVESTIGATED AND DETERMINED THAT THERE WERE NO ISSUES WITH THE CUSTOMER'S REPORTED APPLICATION THAT WOULD HAVE LED TO THE COMPLAINT. THE USER REPORTED SPECIFIC QUESTION/CONCERN WITH SNOOZING OR DISMISSING OF THE ALARMS. THE REPORTED ISSUE WAS INVESTIGATED AND ATTEMPTED TO REPLICATE USING SIMILAR CONFIGURATION AND THE REPORTED ISSUE WAS UNABLE TO BE REPLICATED AND THE SYSTEM FUNCTIONED AS INTENDED. THEREFORE, THE ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN EMAIL COMPLAINT WAS RECEIVED IN WHICH AN UNEXPECTED APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION, IN USE WITH NOTHING PHONE 1 WITH ANDROID OPERATING SYSTEM VERSION 13. THE CUSTOMER'S FREESTYLE LIBRELINKUP APPLICATION WAS SHOWING "UNEXPECTED APPLICATION ERROR" MESSAGE. THE CAREGIVER WAS UNSURE WHETHER THE OTHER USER OF THE SAME ACCOUNT TURNED OFF THEIR NOTIFICATIONS OR ACKNOWLEDGED THE ALERT WITHOUT TAKING ACTION, AND IF THIS AFFECTED THE MAIN USER'S APPLICATION. AS A RESULT, THE CAREGIVER WAS NOT NOTIFIED VIA THE LINKUP APPLICATION OF CUSTOMER'S GLYCEMIC STATUS. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS LED THEM BEING TAKEN TO A HOSPITAL, WHERE THEY WERE DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA, REPORTEDLY RESULTED "BRAIN DAMAGE" AND RECEIVED UNSPECIFIED TREATMENT BY A HEALTHCARE PROFESSIONAL (HCP). HCP SUSPECTED THAT THIS MIGHT HAVE BEEN CAUSED BY THE HYPOGLYCEMIA, BUT THEY COULD NOT CONFIRM A DIRECT LINK. AT THE SAME TIME, THEY WERE UNABLE TO DETERMINE ANY OTHER SPECIFIC CAUSE FOR THE SLEEP APNEA AND "BRAIN DAMAGE". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN EMAIL COMPLAINT WAS RECEIVED IN WHICH AN UNEXPECTED APPLICATION ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) APPLICATION, IN USE WITH NOTHING PHONE 1 WITH ANDROID OPERATING SYSTEM VERSION 13 AND UNKNOWN APP VERSION. THE CUSTOMER'S FREESTYLE LIBRELINKUP APPLICATION WAS SHOWING "UNEXPECTED APPLICATION ERROR" MESSAGE. THE CAREGIVER WAS UNSURE WHETHER THE OTHER USER OF THE SAME ACCOUNT TURNED OFF THEIR NOTIFICATIONS OR ACKNOWLEDGED THE ALERT WITHOUT TAKING ACTION, AND IF THIS AFFECTED THE MAIN USER'S APPLICATION. AS A RESULT, THE CAREGIVER WAS NOT NOTIFIED VIA THE LINKUP APPLICATION OF CUSTOMER'S GLYCEMIC STATUS. THE CUSTOMER EXPERIENCED HYPOGLYCEMIA AND LOSS OF CONSCIOUSNESS. THIS LED THEM BEING TAKEN TO A HOSPITAL, WHERE THEY WERE DIAGNOSED WITH OBSTRUCTIVE SLEEP APNEA, REPORTEDLY RESULTED "BRAIN DAMAGE" AND RECEIVED UNSPECIFIED TREATMENT BY A HEALTHCARE PROFESSIONAL (HCP). HCP SUSPECTED THAT THIS MIGHT HAVE BEEN CAUSED BY THE HYPOGLYCEMIA, BUT THEY COULD NOT CONFIRM A DIRECT LINK. AT THE SAME TIME, THEY WERE UNABLE TO DETERMINE ANY OTHER SPECIFIC CAUSE FOR THE SLEEP APNEA AND "BRAIN DAMAGE". THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604642 FREESTYLE LIBRELINKUP FLASH GLUCOSE MONITORING SYSTEM PJT ABBOTT DIABETES CARE LTD 72154-01 00357599824006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention