BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 20139647 · Received September 4, 2024

    Report

    Report Number
    3019004087-2024-00388
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    August 5, 2024
    Report Date
    September 4, 2024
    Manufacturer
    BETA BIONICS
    Product Code
    QFG
    UDI-DI
    850050080015
    PMA / PMN Number
    K231485
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED FOR EVALUATION. DATA UPLOADS FROM THE ILET WERE NOT COMPLETED AFTER 7/13/24, PRIOR TO THE PRESUMED EVENT DATE; CGM GLUCOSE DATA WERE THEREFORE NOT AVAILABLE TO CONFIRM THE EVENT, AND ILET PERFORMANCE DURING THE EVENT COULD NOT BE EVALUATED. NO PRODUCT PERFORMANCE ISSUES CAN BE IDENTIFIED. IF THE PRODUCT IS RECEIVED AT A LATER DATE, OR THE ILET DATA IS UPLOADED, THE COMPLAINT WILL BE REOPENED AND INVESTIGATED ACCORDINGLY. THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THIS DEVICE PASSED ALL MANUFACTURING RELEASE CRITERIA FOR DISTRIBUTION. THERE WERE NO ISSUES IDENTIFIED THAT WOULD HAVE IMPACTED THIS EVENT. WITHOUT DEVICE DATA FROM THE REPORTED EVENT DATE, THE PERFORMANCE OF THE DEVICE DURING THE EVENT CANNOT BE EVALUATED AND THE CAUSE OF THE EVENT CANNOT BE DETERMINED. HOWEVER, BASED ON THE USER'S REPORT, IT IS LIKELY THAT THE USER FAILED TO FOLLOW INSTRUCTIONS IN THE DEVICE LABELING AND USER INTERFACE WHEN COMPLETING THE CARTRIDGE CHANGE PROCESS LEADING TO UNINTENTIONAL INSULIN DELIVERY THAT REQUIRED INTERVENTION TO PREVENT A SEVERE HYPOGLYCEMIC EVENT.

    Description of Event or Problem · 0

    ON (B)(6) 2024 A BETA BIONICS A CLINICAL DIABETES SPECIALIST (CDS) WAS MADE AWARE THAT AN ILET USER WAS EXPERIENCING AN ERROR WITH THEIR ILET DEVICE, INDICATING IT WAS UNABLE TO DELIVER INSULIN. A CUSTOMER CARE AGENT CONTACTED THE USER. UPON TROUBLESHOOTING, IT WAS DETERMINED THAT THE ERROR WAS CAUSED BY THE USER RUNNING OUT OF INSULIN AND FAILING TO REWIND THE PISTON IN THE CARTRIDGE CHAMBER BEFORE INSERTING A NEW INSULIN CARTRIDGE. THIS LED TO AN EXCESSIVE INSULIN DELIVERY. THE USER, WHO HAD BEEN CONSUMING FAST-ACTING CARBS, REPORTED A BLOOD GLUCOSE LEVEL OF 70 MG/DL AT THE TIME OF THE CALL. THE AGENT ADVISED THE USER TO SEEK IMMEDIATE MEDICAL ATTENTION. THE USER AGREED TO HAVE ONE OF THEIR CHILDREN DRIVE THEM AND PLANNED TO CALL THE HOSPITAL RIGHT AWAY. A FOLLOW-UP TRAINING SESSION WAS REQUESTED BEFORE THE USER RECONNECTS TO THE ILET. LATER THE SAME DAY, THE USER CALLED AGAIN AND REPORTED THEIR DOCTOR'S OFFICE WAS CLOSED DUE TO WEATHER. AS A RESULT, NO PROFESSIONAL MEDICAL TREATMENT WAS RECEIVED. THE USER REPORTED A SLIGHT HEADACHE AND DIZZINESS. NO FURTHER HEALTH EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900188 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS BB1001 NA 850050080015

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention