BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 PODS

    MDR report key: 25123925 · Received May 8, 2026

    Report

    Report Number
    3014585508-2026-26752
    Event Type
    Death
    Date Received
    May 8, 2026
    Date of Event
    April 6, 2026
    Report Date
    May 8, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000579
    PMA / PMN Number
    K231826
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE PHYSICAL DEVICE WAS NOT RECEIVED FOR INVESTIGATION. A BATCH OF USER-INITIATED LOG FILES PACKAGED ON (B)(6) 2026 FROM THE CONTROLLER SERIAL NUMBER REPORTED IN THE COMPLAINT WAS DOWNLOADED AND REVIEWED. REVIEW OF THE LOG FILES FOUND THAT THE POD REPORTED WAS ACTIVATED AT 21:56 ON (B)(6) 2026. REVIEW OF THE PATIENT HISTORY BUFFER (PHB) AUDIT LOG FILES FOUND THAT THE POD LOST COMMUNICATION WITH THE CONTROLLER AT 23:13 ON (B)(6) 2026. REVIEW OF THE PHB DATA FOUND THAT, WHILE THE SYSTEM WAS USED IN AUTOMATED MODE, THE AUTOMATED ALGORITHM WAS ABLE TO APPROPRIATELY ADJUST THE MICROBOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS. THE PHB DATA AND LOG FILES SHOWED THAT THE POD WAS USED IN AUTOMATED MODE FROM THE START OF ACTIVATION UNTIL THE MODE WAS SWITCHED TO MANUAL MODE AT 05:58 ON (B)(6) 2026 TO CHANGE THE SENSOR. THE MODE WAS NOT SWITCHED BACK TO AUTOMATED MODE BEFORE THE POD LOST CONNECTION WITH THE CONTROLLER AFTER 23:13 ON (B)(6) 2026. WHILE THE SYSTEM WAS USED IN MANUAL MODE, THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM OF 1.1 U PER HOUR FOR 24 HOURS REGARDLESS OF THE ESTIMATED GLUCOSE VALUES RECEIVED. THE PHB DATA SHOWED THAT THE POD LOST CONNECTION WITH THE SENSOR AT 19:33 ON (B)(6)2026 WHILE THE SYSTEM WAS IN MANUAL MODE. THE CONNECTION WAS NOT ABLE TO BE REESTABLISHED BEFORE THE POD LOST CONNECTION WITH THE CONTROLLER. THE LAST ESTIMATED GLUCOSE VALUE RECEIVED BY THE POD FROM THE SENSOR PRIOR TO THE POD-SENSOR CONNECTION LOSS WAS 310 MG/DL AT 19:28 ON (B)(6) 2026. THE LOG FILES SHOWED THAT TWO BOLUSES OF 5.6 U WERE DELIVERED WITH THIS POD, ONE AT 22:54 ON (B)(6) 2026 AND ONE AT 12:27 ON (B)(6)2026. THE TOTAL PULSES DELIVERED COUNT TRACKED BY THE POD WAS SEEN TO INCREASE CORRECTLY BASED ON THE TOTAL BOLUS VOLUME FOR EACH BOLUS AFTER DELIVERY OF EACH BOLUS, INDICATING THAT EACH BOLUS WAS ACTIVELY DELIVERED BY THE POD. NO HAZARD ALARMS OR ALERTS WERE GENERATED BY THIS POD. NO EVIDENCE OF ISSUES WITH THE SYSTEM WAS OBSERVED IN THE AVAILABLE LOG FILES. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. LOCKED DOWN SMARTPHONE: PHONE_CONTROL_IOS OMNIPOD SOFTWARE APP VERSION: 2.1.0 OPERATING SYSTEM: 26.3 HARDWARE: IPHONE14.7 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

    IT WAS REPORTED THAT THE PATIENT WAS FOUND AFTER THEY HAD COLLAPSED ON THE STAIRS AT HOME ON (B)(6) 2026. EMERGENCY SERVICES WERE CONTACTED AND CARDIOPULMONARY RESUSCITATION (CPR) WAS ADMINISTERED, HOWEVER WAS UNSUCCESSFUL AND THE PATIENT PASSED AWAY THAT DAY AT HOME AND WERE NOT TRANSPORTED FOR FURTHER MEDICAL TREATMENT. THE PATIENT'S BLOOD GLUCOSE WAS BETWEEN 181- 250 MG/DL AND THEY HAD NOT BEEN HAVING ANY KNOWN ISSUES WITH THE OMNIPOD SYSTEM. THE PATIENT HAD A MEDICAL HISTORY INCLUDING A PACEMAKER, DIABETIC NEUROPATHY WITH ESSENTIAL TREMORS, RESTLESS LEG SYNDROME, MACULAR DEGENERATION, AND SKIN CANCER. THEY WERE GOING TO HAVE A HEART VALVE REPLACEMENT, HOWEVER PASSED AWAY PRIOR TO THAT OCCURRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424717 OMNIPOD 5 PODS OMNIPOD 5 PODS QFG INSULET CORPORATION PT-001662 PH1M10242511 20385083000579

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death