BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 POD

    MDR report key: 20796870 · Received November 27, 2024

    Report

    Report Number
    3004464228-2024-48195
    Event Type
    Death
    Date Received
    November 27, 2024
    Date of Event
    November 8, 2024
    Report Date
    November 27, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DURING A CALL WITH INSULET AND A DEXCOM REPRESENTATION, THE ATTENDING HCP PROVIDED THE FOLLOWING DETAILS: PATIENT WAS A WELL CONTROLLED TYPE 1 DIABETIC WHO WAS ON OMNIPOD 5 SINCE 2022. PATIENT WAS USING OP5 WITH A DEXCOM G6 CGM SENSOR. PATIENT WAS A 20 YR OLD FEMALE WHO SHARED THE DEXCOM CLARITY APP WITH FAMILY FOR VISIBILITY IN HER CARE. (B)(6) 2024, THE PATIENT CONTACTED HER PARENTS TO DISCUSS BRINGING MORE SUPPLIES TO HER AT COLLEGE. (B)(6) 2024 AT 22:46 THE CGM STOPPED PROVIDING READINGS IN THE CLARITY APP. LAST KNOWN READING PER THE PARENTS- 76. (B)(6) 2024, PARENTS TEXT MESSAGES TO THE PATIENT WENT UNANSWERED. (B)(6) 2024, THE FAMILY CONTACTED LOCAL AUTHORITIES TO DO A WELLNESS CHECK AND THE PATIENT WAS FOUND EXPIRED. AUTOPSY IS PENDING. INSPECTION OF THE POD MANAGER HISTORY AND PATIENT HISTORY BUFFER FILES SHOWED THAT ON (B)(6) 2024 AT 22:51 THERE WAS NO LONGER AN ACTIVE CGM SENSOR, AND THE POD WAS NOT RECEIVING ANY ESTIMATED GLUCOSE VALUES. THE SYSTEM CORRECTLY SWITCHED INTO AUTOMATED MODE: LIMITED AFTER 20 MINUTES OF MISSING CGM SENSOR VALUES AND DELIVERED INSULIN AT THE LOWER OF THE USER¿S ADAPTIVE BASAL RATE AND MANUAL MODE BASAL RATE, AS EXPECTED. THE CONTROLLER WAS SHOWN TO GIVE MISSING CGM SENSOR ALERTS EVERY HOUR BEFORE THE POD WAS DEACTIVATED AT 04:43 ON (B)(6) 2024 DUE TO AN EXPIRATION ALARM AFTER 80 HOURS OF USE, WHICH IS AN EXPECTED SAFETY FEATURE OF THE SYSTEM. BASED ON THE AVAILABLE INFORMATION, THE OMNIPOD 5 OPERATED AS INTENDED.

    Description of Event or Problem · 0

    INSULET BECAME AWARE OF A PATIENT EXPIRING WHILE USING THE OMNIPOD 5 SYSTEM WITH A DEXCOM CGM (CONTINUOUS GLUCOSE MONITORING).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367325 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001827 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Death