BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BETA BIONICS INC.

    MDR report key: 24769797 · Received April 2, 2026

    Report

    Report Number
    3019004087-2026-40878
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    October 4, 2025
    Report Date
    April 2, 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

    MANUFACTURER REVIEW DETERMINED THAT THE REPORTED EVENT IS CONSISTENT WITH A PREVIOUSLY IDENTIFIED AND WELL-CHARACTERIZED FAILURE MODE THAT HAS BEEN DOCUMENTED IN PRIOR COMPLAINTS AND INVESTIGATIONS FOR THIS DEVICE. THE FAILURE MECHANISM AND ASSOCIATED POTENTIAL HARMS ARE ALREADY KNOWN AND HAVE BEEN EVALUATED THROUGH EARLIER INVESTIGATIONS. 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 THE ILET SLEEP/WAKE FUNCTION WAS INTERMITTENTLY UNRESPONSIVE, WITH INCONSISTENT ACTIVATION AND UNCERTAIN HAPTIC FEEDBACK, AND NORMAL OPERATION TEMPORARILY RESTORED AFTER A DEVICE RESTART AND CLEANING; THE DEVICE WAS SUBSEQUENTLY REPLACED AS THE ISSUE PERSISTED. SYMPTOMS INCLUDED NONE RELATED TO GLYCEMIA. OUTCOMES INCLUDED NO IMPACT ON BLOOD GLUCOSE, NO MEDICAL INTERVENTION, AND NO HOSPITALIZATION. INVESTIGATION INCLUDED REMOTE TROUBLESHOOTING, USER EDUCATION, AND FOLLOW-UP COMMUNICATIONS. INVESTIGATION OF THIS CASE REVEALED THAT THE ISSUE WAS REPRODUCIBLE INTERMITTENTLY BY THE USER AND THAT PERFORMANCE IMPROVED TRANSIENTLY AFTER RESTART AND CLEANING, SUGGESTING A DEVICE COMPONENT PERFORMANCE ISSUE ASSOCIATED WITH THE SLEEP/WAKE INTERFACE. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS TRACED TO COMPONENT FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    832535 BETA BIONICS INC. ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Unknown