BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24003289 · Received January 8, 2026

    Report

    Report Number
    3019004087-2026-20276
    Event Type
    Malfunction
    Date Received
    January 8, 2026
    Date of Event
    January 5, 2026
    Report Date
    January 8, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION DESCRIPTION. COMPLAINT WAS CONFIRMED; HOWEVER, IT COULD NOT BE DUPLICATED DURING TROUBLESHOOT TESTING. ENGINEERING LOGS INDICATED ALERT 38. MULTIPLE DRY LEADSCREW RUNS WERE COMPLETED SUCCESSFULLY WITH NO ISSUES. THE DEVICE WAS OPENED FOR FURTHER INVESTIGATION AND NO ABNORMALITIES WERE OBSERVED. THE CAUSE FOR THE ISSUE IS UNDETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ILET DISPLAYED AN ¿UNABLE TO PROCEED¿ CONDITION DURING A SUPPLY CHANGE WITH REPEATED ALERT 38 FOR CONSECUTIVE STALLED MOTOR DESPITE MULTIPLE RESTARTS, PREVENTING THE USER FROM REWINDING AND PROCEEDING WITH SETUP; THE REPORT INCLUDED CARTRIDGE LOT 34785, CONNECTOR LOT 34376, INFUSION SET LOT 34217, AND DEVICE SERIAL A140623, WITH NO EFFECT ON BLOOD GLUCOSE. SYMPTOMS INCLUDED NO ADVERSE CLINICAL EFFECTS REPORTED. OUTCOMES INCLUDED NO IMPACT ON DAILY ACTIVITIES REQUIRING MEDICAL INTERVENTION AND NO HOSPITALIZATION. INVESTIGATION INCLUDED REVIEW OF DEVICE LOGS AND USER-REPORTED TROUBLESHOOTING, WITH PLANS FOR DEVICE RETURN FOR EVALUATION. INVESTIGATION OF THIS CASE REVEALED A SUSPECTED MOTOR STALL MALFUNCTION RELATED TO THE PUMP DRIVE MECHANISM THAT BLOCKED THE REWIND AND SETUP PROCESS. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS INDETERMINATE PENDING PHYSICAL ANALYSIS OF THE RETURNED DEVICE. IF THE DEVICE IS RETURNED, A PHYSICAL EVALUATION WILL BE PERFORMED, AND A SUPPLEMENTAL WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66974 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Unknown