BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24621768 · Received March 17, 2026

    Report

    Report Number
    3019004087-2026-38491
    Event Type
    Malfunction
    Date Received
    March 17, 2026
    Date of Event
    March 3, 2026
    Report Date
    March 17, 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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INFUSION SET TUBING BECAME DETACHED FROM THE CONNECTOR WHILE THE TUBING REMAINED ATTACHED TO THE BODY, AND THE CARTRIDGE AND CONNECTOR STAYED IN THE PUMP CHAMBER. THE USER WAS ON A CONTACT DETACH INFUSION SET FROM LOT # 6012522. THE USER COMPLETED A FULL SUPPLY CHANGE BEFORE RESUMING INSULIN DELIVERY. NO REPORTED SYMPTOMS OR ADVERSE CLINICAL EFFECTS. OUTCOMES INCLUDED NO REPORTED IMPACT SUCH AS HOSPITALIZATION OR MEDICAL INTERVENTION. INVESTIGATION INCLUDED TROUBLESHOOTING AND USER EDUCATION. INVESTIGATION OF THIS CASE REVEALED A CONNECTION ISSUE CONSISTENT WITH AN INFUSION SET DEPLOYED OR ATTACHED INCORRECTLY BETWEEN THE TUBING AND THE CONNECTOR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER-RELATED HANDLING OR ATTACHMENT ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679963 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Unknown DEXCOM G7 CONTINUOUS GLUCOSE MONITOR