BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 19969194 · Received August 12, 2024

    Report

    Report Number
    3004464228-2024-31636
    Event Type
    Death
    Date Received
    August 12, 2024
    Date of Event
    June 26, 2024
    Report Date
    January 28, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED THE REPORTED PATIENT'S DEATH. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. NO ANDROID LOG FILES WERE UPLOADED TO THE CLOUD SYSTEM. REVIEW OF AVAILABLE CLOUD DATA SHOWED NO ABNORMALITIES. SYSTEM WAS USED IN MANUAL MODE DELIVERING USER-PROGRAMMED BASAL PROFILE FOR THE DAYS LEADING UP TO DATE OF OCCURRENCE. THE SYSTEM WAS NOT RECEIVING BGS FROM A SENSOR FOR THIS PERIOD AND THE USER WAS MADE AWARE THROUGH ALERTS. CONTROLLER WAS OFF FOR A PERIOD STARTING ON (B)(6) 2024 AND ENDING ON (B)(6) 2024. LAST DATA POINT WAS GENERATED ON (B)(6) 2024. CLOUD DATA SHOWS CONTROLLER IN USE WAS OF SN (B)(6). CONTROLLER SN ALSO REGISTERED TO USER (B)(6) WAS NOT USED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED DEVICE FOUND NO EVIDENCE OF AN OVERDELIVERY OF INSULIN. INVESTIGATION OF THE ANDROID LOG FILES DOWNLOADED FROM THE RETURNED CONTROLLER FOUND NO EVIDENCE OF AN OVERDELIVERY OF INSULIN. THE LOGS SHOWED THAT THE SYSTEM WAS APPROPRIATELY ADAPTING THE AUTOMATED BASAL INSULIN WHILE RECEIVING VALID ESTIMATED GLUCOSE VALUES (EGV) FROM THE CONTINUOUS GLUCOSE MONITOR (CGM). FOR THE LAST WEEK OF USE, THE POD WAS RECEIVING EGVS OF 1, INDICATING THAT THE SENSOR SESSION WAS NOT ACTIVE, AND -1 AND -2 FROM THE CGM, INDICATING CONNECTION ISSUES BETWEEN THE POD AND CGM. THE SYSTEM CORRECTLY RESPONDED TO THE MISSING CGM VALUES, PUTTING THE SYSTEM INTO AUTOMATED MODE: LIMITED AND GENERATING MISSING SENSOR VALUES ALERTS. THE SYSTEM WAS CORRECTLY DELIVERING THE USER'S CONSERVATIVE ADAPTIVE BASAL RATE WHILE IN LIMITED MODE. THE LOGS SHOW THAT THE LAST POD USED WAS USED MOSTLY IN MANUAL MODE WITH THE SYSTEM CORRECTLY DELIVERING THE USER'S MANUAL BASAL PROGRAM. A NEW CGM WAS PAIRED WITH THE LAST POD AND WAS ABLE TO BRIEFLY TRANSMIT VALID BLOOD GLUCOSE VALUES, WHICH WERE URGENT LOW VALUES, BEFORE THE CGM STARTED TRANSMITTING ABERRANT VALUES AND WENT INACTIVE. THE SYSTEM CORRECTLY RESPONDED BY GENERATING THE URGENT LOW GLUCOSE ALERT, HOWEVER THESE VALUES DID NOT INFLUENCE INSULIN AMOUNTS DELIVERED AS THE SYSTEM WAS IN MANUAL MODE AT THE TIME. PHYSICAL TESTING OF THE RETURNED CONTROLLER SHOWED NO ISSUES THAT WOULD CONTRIBUTE TO ISSUES WITH CGM CONNECTIVITY OR CONTRIBUTE TO AN OVERDELIVERY OF INSULIN. THE CONTROLLER WAS DETERMINED TO HAVE FUNCTIONED AS INTENDED.

    Additional Manufacturer Narrative · 0

    ADDED INFORMATION TO D4, LOT NUMBER, SERIAL NUMBER, UDI.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT PASSED AWAY DUE TO A HYPOGLYCEMIC EVENT AND WAS EXPERIENCING FLUCTUATIONS IN BLOOD GLUCOSE (BG) LEVELS, AS WELL AS, HAVING TECHNICAL ISSUES WITH THE CONTINUOUS GLUCOSE MONITOR (CGM). REPORTEDLY, THE HEALTHCARE PROFESSIONAL (HCP) HAS POSSESSION OF THE OMNIPOD 5 CONTROLLER- ATTEMPTS ARE BEING MADE TO RETRIEVE THE DEVICE. THE SERIAL NUMBER OF THE LAST DEVICE TO COMMUNICATE WITH THE CLOUD WAS IN MANUAL MODE AND DELIVERING THE PROGRAMMED BASAL RATE. NO BG VALUES WERE BEING RECEIVED FROM A SENSOR AND THE DEVICE WAS GETTING THE MISSING SENSOR VALUES ALERT. THERE'S A GAP IN THE DATA BETWEEN (B)(6) 2024 AND (B)(6) 2024 THAT WOULD INDICATE THE CONTROLLER WAS OFF FOR THIS PERIOD. LAST DATA POINT WAS ON (B)(6) 2024. AT THIS TIME, THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2247464 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 H000481 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Death