BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ILET BIONIC PANCREAS

    MDR report key: 24109383 · Received January 19, 2026

    Report

    Report Number
    3019004087-2026-22740
    Event Type
    Malfunction
    Date Received
    January 19, 2026
    Date of Event
    March 15, 2025
    Report Date
    January 19, 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 THE DEXCOM G7 CONTINUOUS GLUCOSE MONITOR FAILED TO MAINTAIN PAIRING WITH THE ILET, RESULTING IN LOSS OF AUTOMATED INSULIN DOSING AND RELIANCE ON MANUAL BLOOD GLUCOSE ENTRY; TROUBLESHOOTING STEPS INCLUDED SWITCHING BETWEEN G6 AND G7 SETTINGS AND REENTERING THE SENSOR PAIRING CODE, WITH REPEATED PAIRING FAILURES. SYMPTOMS INCLUDED HYPERGLYCEMIA WITH REPORTED READINGS AROUND 243¿247 MG/DL WITHOUT ASSOCIATED PHYSICAL SYMPTOMS. OUTCOMES INCLUDED TEMPORARY DISCONTINUATION OF AUTOMATED THERAPY, USE OF SUBCUTANEOUS INSULIN BY PEN FOR BASAL COVERAGE, AND PLANNED FOLLOW-UP WITH A HEALTHCARE PROVIDER. INVESTIGATION INCLUDED CUSTOMER-GUIDED TROUBLESHOOTING, EDUCATION ON DEVICE SETTINGS, AND MONITORING INSTRUCTIONS WITH FOLLOW-UP CALLS. INVESTIGATION OF THIS CASE REVEALED RECURRENT COMMUNICATION FAILURE BETWEEN THE CGM AND THE ILET WITHOUT EVIDENCE OF DEVICE ALARMS FOR HIGH OR LOW GLUCOSE DUE TO THE DISCONNECTED SENSOR. IT WAS CONCLUDED, BASED ON PREVIOUSLY ESTABLISHED FINDINGS FOR SIMILAR REPORTS, THAT THE CAUSE WAS USER-DEVICE COMMUNICATION FAILURE WITH UNDETERMINED ROOT CAUSE PENDING FURTHER CLINICAL EVALUATION AND DEVICE CONFIGURATION REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170898 ILET BIONIC PANCREAS ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG BETA BIONICS INC. BB1001 00850050080190

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Unknown