BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 23986093 · Received January 6, 2026

    Report

    Report Number
    3019004087-2026-19820
    Event Type
    Malfunction
    Date Received
    January 6, 2026
    Date of Event
    June 10, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BETA BIONICS INC.
    Product Code
    QFG
    UDI-DI
    00850050080190
    PMA / PMN Number
    K231485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS MDR IS PART OF A REMEDIAL SUBMISSION MADE IN RESPONSE TO FDA FORM 483 OBSERVATIONS TO ENSURE FULL REPORTING COMPLIANCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A USER EXPERIENCED THREE CONSECUTIVE INSET 23" 6 MM INFUSION SETS THAT WOULD NOT LOCK WHEN ATTEMPTING TO COCK THE SPRING-LOADED INSERTER, DESPITE MULTIPLE ATTEMPTS BY DIFFERENT INDIVIDUALS, AND A REPLACEMENT SUPPLY WAS ARRANGED. SYMPTOMS INCLUDED NO REPORTED ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED NO ALARMS AND NO NEED FOR MEDICAL CARE. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION CONDUCTED REMOTELY. INVESTIGATION OF THIS CASE REVEALED AN INFUSION SET DEPLOYMENT ISSUE CONSISTENT WITH AN INSERTION MECHANISM THAT DID NOT ENGAGE AS INTENDED, ASSOCIATED WITH THE INFUSION SET AND ITS INSERTER ASSEMBLY, WITH THE AFFECTED LOT IDENTIFIED AS 6010684. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS LIKELY USER-DEVICE INTERFACE OR PRODUCT PERFORMANCE VARIABILITY NOT REPRODUCED DURING REMOTE TROUBLESHOOTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47593 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown