BEUDAMED
    FDA Adverse Event Death Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 19800022 · Received July 22, 2024

    Report

    Report Number
    3004464228-2024-27774
    Event Type
    Death
    Date Received
    July 22, 2024
    Date of Event
    June 26, 2024
    Report Date
    October 2, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO DETERMINE IF ANY PRODUCT CONDITION COULD HAVE CONTRIBUTED TO THE REPORTED PATIENT'S PASSING. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION HAS BEEN RECEIVED CONFIRMING THE PATIENT EXPIRED ON (B)(6) 2024 WHILE WEARING THE OMNIPOD DEVICE. THE PHYSICAL DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF CLOUD DATA FOR THE PERIOD OF (B)(6) 2024 FOR THIS USER WAS REVIEWED. THE DATA SHOWED THAT THE AUTOMATED ALGORITHM WAS APPROPRIATELY ADAPTING THE AUTOMATED INSULIN DELIVERY BASED ON THE ESTIMATED GLUCOSE VALUES RECEIVED BY THE POD. THE DATA SHOWED THAT THE ESTIMATED GLUCOSE VALUES STARTED INCREASING AND REACHED URGENT HIGH AT 11:20:40 ON (B)(6) 2024. THE SYSTEM RESPONDED APPROPRIATELY TO THE INCREASING AND HIGH GLUCOSE LEVELS BY DELIVERING THE MAXIMUM AMOUNT OF AUTOMATED INSULIN DETERMINED BY THE USER'S ADAPTIVE BASAL RATE. EXTENDED PERIODS OF THIS MAX INSULIN DELIVERY RESULTED IN AUTOMATED DELIVERY RESTRICTION ALERTS BEING GENERATED AT 12:05:40 AND 16:15:41 ON (B)(6) 2024. AFTER THE AUTOMATED DELIVERY RESTRICTION AT 16:15:41 WAS ACKNOWLEDGED AND THE SYSTEM PUT INTO MANUAL MODE, THE USER KEPT THE SYSTEM IN MANUAL MODE AND THE POD DELIVERED THE USER'S MANUAL BASAL PROGRAM OF 0.8 U/HOUR. MANUAL DELIVERY CONTINUED UNTIL THE LAST DATA POINT AT 17:10:40 ON (B)(6) 2024.

    Additional Manufacturer Narrative · 0

    SECTIONS D1 BRAND NAME CHANGED TO OP5 CONTROLLER AND D4 CHANGED TO THE ASSOCIATED MODEL NUMBER, SERIAL NUMBER, LOT NUMBER, CATALOG NUMBER AND PRIMARY UDI NUMBER. THE DEVICE IS ANTICIPATED TO BE RETURNED. IF THE DEVICE IS RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THE RETURNED DEVICE FOUND NO EVIDENCE OF ISSUES THAT WOULD IMPACT INSULIN DELIVERY. PHYSICAL TESTING OF THE CONTROLLER FOUND IT TO FUNCTION AS INTENDED AT THE TIME OF THE INSPECTION. REVIEW OF THE ANDROID LOG FILES DOWNLOADED FROM THE CONTROLLER FOUND NO EVIDENCE OF ISSUES WITH INSULIN DELIVERY. THE LOGS SHOWED THAT, WHEN IN AUTOMATED MODE, THE AUTOMATED ALGORITHM APPROPRIATELY ADJUSTED MICROBOLUS AMOUNTS BASED ON THE ESTIMATED GLUCOSE VALUES AND USER INPUTS, AND WHEN IN MANUAL MODE THE SYSTEM CORRECTLY DELIVERED THE USER'S MANUAL BASAL PROGRAM. THE RETURNED CONTROLLER WAS DETERMINED TO FUNCTION AS INTENDED.

    Description of Event or Problem · 0

    HEALTH CARE PROFESSIONAL REPORTS THAT THE PATIENT PASSED AWAY WHILE ON OMNIPOD 5 DEVICE (OP5). THE PATIENT HAD HIGH BLOOD GLUCOSE LEVELS OF GREATER THAN 300 MG/DL. THE PATIENT WAS WEARING THE DEVICE AT THE TIME OF DEATH, HOWEVER THERE IS NO ALLEGATION OF A DEVICE MALFUNCTION CONTRIBUTING TO OR CAUSING THE PATIENT DEATH. ADDITIONAL DEVICE/THERAPY INFORMATION HAS BEEN REQUESTED. THIS CASE WILL BE REVIEWED FURTHER IF NEW INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934521 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-001827 H000552 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Death