BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 25228321 · Received May 20, 2026

    Report

    Report Number
    3014585508-2026-29246
    Event Type
    Death
    Date Received
    May 20, 2026
    Date of Event
    October 27, 2025
    Report Date
    May 20, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING AND INSULET IS ATTEMPTING TO RECOVER ADDITIONAL DETAILS. IF ADDITIONAL INFORMATION IS RECEIVED, INSULET WILL SUBMIT A SUPPLEMENTAL REPORT AND CONDUCT ALL POSSIBLE INVESTIGATION. THE PHYSICAL DEVICE WAS NOT RETURNED. THE INSULET CLOUD SYSTEM WAS CHECKED FOR DATA FROM THE USER FOR THE PERIOD OF (B)(6) 2025. DATA WAS ONLY FOUND TO BE AVAILABLE FOR (B)(6) 2025. THE CLOUD DATA FOR THIS PERIOD WAS DOWNLOADED AND REVIEWED. REVIEW OF THE PATIENT HISTORY BUFFER (PHB) DATA FOUND THAT THE ESTIMATED GLUCOSE VALUES REGULARLY INCREASED TO URGENT HIGH (GREATER THAN 500 MG/DL) DURING THIS PERIOD. THE PHB DATA SHOWED THAT, WHILE IN AUTOMATED MODE, THE AUTOMATED ALGORITHM WAS ABLE TO APPROPRIATELY ADJUST THE MICROBOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS. THE AUTOMATED ALGORITHM APPROPRIATELY INCREASED THE MICROBOLUS AMOUNTS AS ESTIMATED GLUCOSE VALUES INCREASED TOWARDS URGENT HIGH UNTIL THE MAXIMUM MICROBOLUS AMOUNT WAS REACHED. THE CLOUD DATA SHOWED THAT MULTIPLE AUTOMATED DELIVERY RESTRICTION ALERTS WERE GENERATED DURING THIS PERIOD, ONE AT 01:52 AND ONE AT 23:32 ON (B)(6) 2025, ONE AT 17:07 ON (B)(6) 2025, ONE AT 01:14, ONE AT 10:49, AND ONE AT 15:44 ON (B)(6) 2025, AND ONE AT 07:14 ON (B)(6) 2025. ALL OF THESE WERE DUE TO THE AUTOMATED ALGORITHM DELIVERING THE MAX MICROBOLUS AMOUNT FOR AN EXTENDED PERIOD IN RESPONSE TO INCREASING AND HIGH ESTIMATED GLUCOSE VALUES. ACKNOWLEDGEMENT OF THESE ALERTS FORCED THE SYSTEM TO TRANSITION FROM AUTOMATED MODE TO MANUAL MODE. THE PHB DATA SHOWED THAT AFTER ACKNOWLEDGEMENT OF THE LAST AUTOMATED DELIVERY RESTRICTION ALERT, THE SYSTEM TRANSITIONED TO MANUAL MODE AND REMAINED IN MANUAL MODE THROUGH THE LAST PHB DATA POINT AT 15:28 ON (B)(6) 2025. WHILE IN MANUAL MODE, THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM OF 0.5 U PER HOUR FOR 24 HOURS REGARDLESS OF THE ESTIMATED GLUCOSE VALUES RECEIVED. THE PHB DATA SHOWED THAT THE LAST INCREASE FROM BELOW URGENT HIGH ESTIMATED GLUCOSE VALUES TO URGENT HIGH GLUCOSE VALUES OCCURRED BETWEEN 18:23 ON (B)(6) 2025 AND 21:38 ON (B)(6) 2025 WHEN ESTIMATED GLUCOSE VALUES INCREASED FROM 325 MG/DL TO URGENT HIGH. THE ESTIMATED GLUCOSE VALUES REMAINED AT URGENT HIGH THROUGH THE LAST PHB DATAPOINT. THE LAST POD ACTIVATION WAS RECORDED AT 07:33 ON (B)(6) 2025. A DEACTIVATION OR DISCARD RECORD WAS NOT RECEIVED BY THE CLOUD AFTER THIS ACTIVATION RECORD, INDICATING THAT THE CONTROLLER LOST CONNECTION WITH THE CLOUD BEFORE THE POD COULD BE DEACTIVATED OR DISCARDED. THE PHB DATA SHOWED THAT THE FIRST ESTIMATED GLUCOSE VALUE RECEIVED BY THIS POD WAS URGENT HIGH AT 07:38 ON (B)(6) 2025. ESTIMATED GLUCOSE VALUES WERE ABLE TO DECREASE TO 113 MG/DL AT 13:03 ON (B)(6) 2026 BEFORE INCREASING AGAIN TO URGENT HIGH AT 17:43 ON (B)(6) 2025. THE CLOUD DATA SHOWED MULTIPLE BOLUS RECORDS DURING THIS PERIOD, WITH THE LAST BOLUS DELIVERED BEING AN 8.5 U BOLUS STARTED AT 09:19 ON (B)(6) 2025. NO EVIDENCE OF ISSUES WITH INSULIN DELIVERY OR OF ANY OTHER ISSUES WITH THE SYSTEM WAS OBSERVED IN THE AVAILABLE CLOUD DATA. IT COULD NOT BE CONCLUSIVELY DETERMINED IF THE CONTROLLER REMAINED IN USE AFTER(B)(6) 2025 WITHOUT A CONNECTION TO THE CLOUD OR IF THE USER ENDED USE OF THE SYSTEM ON (B)(6) 2025 BASED ON THE AVAILABLE CLOUD DATA. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: DATA NOT AVAILABLE. OMNIPOD SOFTWARE APP VERSION: 3.1.5-P001. OPERATING SYSTEM: N5004L-AM-Q-MV01602-06-01.06. HARDWARE: N5004L. CGM SENSOR TYPE: DATA NOT AVAILABLE. 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

    IT WAS REPORTED TO INSULET ON (B)(6) 2026 VIA EMAIL, THAT A PATIENT HAD PASSED AWAY ON (B)(6) 2025. THE PATIENT IS REPORTED TO HAVE BEEN USING THE OMNIPOD 5 SYSTEM AT THE TIME OF PASSING. A CORONER HAS CONTACTED INSULET ON (B)(6) 2026 TO OBTAIN THE PATIENT'S GLOOKO DATA. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN PROVIDED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67628 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-002121 H000634 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Death