BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 APP

    MDR report key: 23020494 · Received September 10, 2025

    Report

    Report Number
    3004464228-2025-41023
    Event Type
    Death
    Date Received
    September 10, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 10, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CLOUD DATA FOR THE PERIOD 01AUG2025- (B)(6) 2025 WAS REVIEWED. THE LAST AVAILABLE DATA POINT AVAILABLE IN THE CLOUD IS AT 05:40:28 GMT-5 ON (B)(6) 2025. THE LAST BOLUS DELIVERED WAS A BOLUS OF 3 U DELIVERED AT 05:01:11 GMT-5 ON (B)(6) 2025 BASED ON AN INPUT OF 60 G OF CARBS. THIS BOLUS WAS CORRECTLY CALCULATED BASED ON THE INSULIN-TO-CARB RATIO OF 20. THE PATIENT HISTORY BUFFER (PHB) DATA FROM THE CLOUD SHOWED EVIDENCE OF COMMUNICATION ISSUES BETWEEN THE POD AND THE PAIRED SENSOR STARTING AT 20:25:33 ON (B)(6) 2025 AND GOING UNTIL THE LAST DATA POINT. THE LAST SENSOR VALUE RECEIVED WAS 83 MG/DL AT 20:20:27 GMT-5 ON (B)(6) 2025. THE PHB DATA SHOWED THAT THE SYSTEM RESPONDED APPROPRIATELY TO THE MISSING SENSOR VALUES, SWITCHING TO AUTOMATED MODE: LIMITED AFTER 20 MINUTES AT 20:40:33 GMT-5. THE SYSTEM STOPPED AUTOMATED INSULIN DELIVERY PRIOR TO THE SWITCH TO AUTOMATED MODE: LIMITED AND SO THE SYSTEM DID NOT DELIVER MICROBOLUSES DURING THIS PERIOD. THE SYSTEM OPERATED IN AUTOMATED MODE: LIMITED UNTIL THE MODE WAS SWITCHED TO MANUAL MODE BY THE USER AT 21:20:48 GMT-5 ON 03AUG2025. WHILE IN MANUAL MODE, THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM. THE MODE WAS SWITCHED AGAIN BY THE USER AND THE SYSTEM OPERATED IN AUTOMATED MODE: LIMITED FOR 22:00:32-22:59:18 GMT-5 03AUG2025, DELIVERING THE MINIMUM OF THE USER'S MANUAL BASAL PROGRAM AND THE ADAPTIVE BASAL RATE. THE SYSTEM MODE WAS SWITCHED AGAIN TO MANUAL MODE AT 22:59:18 GMT-5 ON 03AUG2025 AND THE SYSTEM DELIVERED THE USER'S MANUAL BASAL PROGRAM UNTIL A MODE SWITCH BACK TO AUTOMATED MODE: LIMITED AT 05:05:32 GMT-5 ON 04AUG2025. THE DATA SHOWED THAT AFTER THESE LAST TWO SWITCHES TO AUTOMATED MODE: LIMITED, THE SYSTEM GENERATED MISSING SENSOR VALUES ALERTS. THE SYSTEM DELIVERED THE MINIMUM OF THE USER'S MANUAL BASAL PROGRAM AND THE ADAPTIVE BASAL RATE UNTIL THE LAST DATA POINT AVAILABLE. THE DATA SHOWED THAT WHILE THE SYSTEM WAS IN AUTOMATED MODE AND ESTIMATED GLUCOSE VALUES WERE BEING RECEIVED BY THE POD, THE AUTOMATED ALGORITHM WAS CREATING AN INSULIN DELIVERY CALCULATION ONCE EVERY FIVE MINUTES AND THE ALGORITHM WAS ABLE TO APPROPRIATELY ADAPT THE MICRO BOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS. THE ALGORITHM APPROPRIATELY REDUCED AND STOPPED AUTOMATED INSULIN DELIVERY AS ESTIMATED GLUCOSE VALUES DECREASED TOWARDS AND BELOW THE USER'S TARGET. NO EVIDENCE OF AN OVER DELIVERY OF INSULIN WAS OBSERVED IN THE AVAILABLE CLOUD DATA. THERE IS NO EVIDENCE THAT AN INSULET DEVICE MALFUNCTIONED OR CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. CLOUD - LOCKED DOWN/SMARTPHONE PHONE_CONTROL_IOS CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 2.0.2 CLOUD - OPERATING SYSTEM 18.5 CLOUD - HARDWARE IPHONE15.3 CLOUD - CGM SENSOR TYPE G7. *PLEASE NOTE, THE DEVICE IDENTIFIERS ARE CAPTURED AS REPORTED BY THE COMPLAINANT AND MAY NOT ALIGN WITH THE DEVICE CONFIGURATION REPORTED IN THIS SECTION AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    INITIALLY REPORTED VIA A SOCIAL MEDIA POST, A PATIENT PASSED AWAY AS A RESULT OF A HYPOGLYCEMIC EVENT. PER THE POSTING, ON THE MORNING OF THE INCIDENT, THE PATIENT REPLACED THEIR CONTINUOUS GLUCOSE MONITOR (CGM) G7 SENSOR, AND FOLLOWING THE OMNIPOD 5 SMARTBOLUS CALCULATOR'S RECOMMENDATION, DELIVERED A CORRECTION BOLUS FOR A BLOOD GLUCOSE LEVEL OF 250 MG/DL. WHILE EXERCISING, THE PATIENT COLLAPSED AND DID NOT REGAIN CONSCIOUSNESS. THE PATIENT'S SPOUSE INQUIRED IN THE SOCIAL MEDIA POST IF INSULIN COULD HAVE BEEN DELIVERED TWICE BY RECEIVING A SIGNAL FROM BOTH THE OLD AND NEW CGM SENSORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1778402 OMNIPOD 5 APP ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-002343 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Death