BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 POD

    MDR report key: 25071412 · Received May 4, 2026

    Report

    Report Number
    3014585508-2026-25401
    Event Type
    Death
    Date Received
    May 4, 2026
    Date of Event
    January 17, 2026
    Report Date
    May 4, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000753
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PHYSICAL DEVICE WAS NOT RECEIVED FOR ANALYSIS. CLOUD DATA FROM THE USER FOR THE PERIOD OF (B)(6) 2026-(B)(6) 2026 WAS DOWNLOADED AND REVIEWED. REVIEW OF THE PATIENT HISTORY BUFFER (PHB) DATA FOUND 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 PHB DATA SHOWED AN INCREASE FROM 107 MG/DL AT 07:47 ON 16JAN2026 TO URGENT HIGH (GREATER THAN 400 MG/DL) AT 17:07 ON (B)(6) 2026. THE VALUES RECEIVED BY THE POD FROM THE SENSOR REMAINED URGENT HIGH UNTIL SENSOR ABERRATIONS STARTED OCCURRING AT 03:47 ON (B)(6) 2026 AND THE SENSOR BECAME INACTIVE STARTING AT 05:32 ON (B)(6) 2026. THE AUTOMATED ALGORITHM RESPONDED APPROPRIATELY TO THE INCREASE, INCREASING THE MICROBOLUS AMOUNT DELIVERED UNTIL THE MAX MICROBOLUS AMOUNT WAS REACHED AS ESTIMATED GLUCOSE VALUES REACHED CLOSE TO URGENT HIGH. AN AUTOMATED DELIVERY RESTRICTION ALERT WAS GENERATED AT 17:47 ON (B)(6) 2026 DUE TO THE AUTOMATED ALGORITHM DELIVERING THE MAX MICROBOLUS AMOUNT FOR AN EXTENDED PERIOD. THE ALERT WAS ACKNOWLEDGED AND THE SYSTEM SWITCHED TO MANUAL MODE. WHILE IN MANUAL MODE, THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM REGARDLESS OF THE ESTIMATED GLUCOSE VALUES RECEIVED. THE SYSTEM WAS USED IN MANUAL MODE UNTIL 23:37 ON (B)(6) 2026 WHEN THE MODE WAS SWITCHED BACK TO AUTOMATED MODE. ANOTHER AUTOMATED DELIVERY RESTRICTION ALERT WAS GENERATED AT 03:12 ON (B)(6) 2026 DUE TO THE AUTOMATED ALGORITHM DELIVERING THE MAX MICROBOLUS AMOUNT FOR AN EXTENDED PERIOD IN RESPONSE TO THE CONTINUED URGENT HIGH ESTIMATED GLUCOSE VALUES. THE ALERT WAS ACKNOWLEDGED AT 03:32 ON (B)(6) 2026 AND THE SYSTEM TRANSITIONED TO MANUAL MODE. THE SYSTEM REMAINED IN MANUAL MODE UNTIL THE LAST DATA POINT RECEIVED BY THE CONTROLLER FROM THE POD WHICH WAS GENERATED AT 06:07 ON (B)(6) 2026. THE CLOUD DATA SHOWED THAT BOLUSES WERE DELIVERED DURING THIS PERIOD, WITH THE LAST BOLUS BEING AN 8.6 U BOLUS DELIVERED AT 23:30 ON (B)(6) 2026. THE CLOUD DATA SHOWS EVIDENCE THAT ALL BOLUSES RECORDED WERE ACTIVELY DELIVERED, AS THE TOTAL PULSES DELIVERED COUNT TRACKED BY THE POD INCREASED CORRECTLY BASED ON THE TOTAL BOLUS VOLUME OF EACH BOLUS AFTER DELIVERY OF EACH BOLUS. THE CLOUD DATA SHOWED THAT ALERTS, NOTIFICATIONS, AND REMINDERS WERE GENERATED CORRECTLY AS CONDITIONS WERE MET. NO EVIDENCE OF ISSUES WITH THE SYSTEM WAS OBSERVED IN THE AVAILABLE CLOUD DATA. 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: 26.2, HARDWARE: IPHONE12.8, 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 THAT ON (B)(6) 2026, THE PATIENT'S BLOOD GLUCOSE ROSE TO GREATER 500 MG/DL. SYMPTOMS INCLUDE HYPERGLYCEMIA, NAUSEA AND DIZZINESS. AN AMBULANCE WAS CALLED AND THEY SPENT 20 MIN TRYING TO REVIVE HIM IN THE AMBULANCE, WHILE BEING TRANSPORTED THE HOSPITAL. IT WAS REPORTED THAT THE PATIENT HAD ARRIVED AT THE HOSPITAL, WITH THE CARDIAC ARREST, AND HAD PASSED AWAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203467 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001977 PH1U06112531 20385083000753

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Death