BEUDAMED
    FDA Adverse Event Death Summary report: N

    ILET DOSING DECISION SOFTWARE

    MDR report key: 22352603 · Received June 30, 2025

    Report

    Report Number
    MW5172082
    Event Type
    Death
    Date Received
    June 30, 2025
    Report Date
    February 25, 2025
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QJI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    OER RECEIVED A CALL FROM THE FDA EMERGENCY CALL CENTER REPORTING A DEATH IN (B)(6). THE CALLER, (B)(6), IS A DEATH INVESTIGATOR AT (B)(6) REPORTING THE DEATH OF A 56-YEAR-OLD MALE WITH TYPE 1 DIABETES. HIS INSULIN WAS RECENTLY CHANGED, AND HE RECEIVED A NEW PUMP 2-3 WEEKS AGO. THE DEVICE IS A BETA BIONICS ILET BIONIC PANCREAS PUMP. THE FAMILY NOTICED SOME PROBLEMS WITH THE DEVICE, BUT DID NOT PROVIDE ANY SPECIFICS. ON FEBRUARY (B)(6), THE INDIVIDUAL WENT TO BED AND WAS FOUND DECEASED THE NEXT MORNING. FROM THE BIOMETRICS APP OF THE DEVICE, IT WAS OBSERVED THAT THE GLUCOSE LEVEL DECLINED SIGNIFICANTLY AFTER MIDNIGHT ON FEB (B)(6) AND INSULIN DELIVERY EVENTUALLY STOPPED. THE CALLER MENTIONED SEEING INFORMATION ON A PREVIOUS FDA INVESTIGATION FROM 2023 THAT APPEARED SIMILAR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FOR MW5172082 ON 8/14/2025 TO MAKE THE REPORTER UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1234808 ILET DOSING DECISION SOFTWARE INTEROPERABLE AUTOMATED GLYCEMIC CONTROLLER QJI BETA BIONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death