BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 25341195 · Received May 31, 2026

    Report

    Report Number
    3019004087-2026-49254
    Event Type
    Malfunction
    Date Received
    May 31, 2026
    Date of Event
    May 6, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BETA BIONICS, INC.
    Product Code
    QFG
    UDI-DI
    00850050080183
    PMA / PMN Number
    K231485
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ILET DISPLAYED ALERT 55 DURING AN ATTEMPTED INSULIN CHANGE AFTER LOW INSULIN AND SUPPLY-EXPIRED NOTIFICATIONS, AND THE USER COULD NOT DISMISS ALERT 55 OR PROCEED WITH CHANGE CARTRIDGE AND TUBING, CONSISTENT WITH A MECHANICAL PROBLEM ASSOCIATED WITH THE DEVICE AND INTERPRETED AS A CROSS-CHECK CRYSTALS, LSE XTAL MALFUNCTION. SYMPTOMS INCLUDED NO CLINICAL SIGNS, SYMPTOMS, OR CONDITIONS. OUTCOMES INCLUDED NO HEALTH CONSEQUENCES OR IMPACT. INVESTIGATION INCLUDED COMMUNICATION WITH THE USER AND ANALYSIS OF INFORMATION PROVIDED BY THE USER. INVESTIGATION OF THIS CASE REVEALED A MECHANICAL PROBLEM IDENTIFIED WITH THE DEVICE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS A MANUFACTURING DEFICIENCY. 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
    150338 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS, INC. 00850050080183

    Patients

    Seq Age Sex Outcome Treatment
    1