BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 24651264 · Received March 20, 2026

    Report

    Report Number
    3014585508-2026-14964
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 14, 2026
    Report Date
    March 20, 2026
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 HOSPITALIZATION AND HYPERGLYCEMIA. IT WAS REPORTED THE CANNULA WAS POSSIBLY NOT INSERTED CORRECTLY INTO THE INFUSION SITE. THIS CONDITION COULD INTERRUPT INSULIN DELIVERY AND CONTRIBUTE TO HYPERGLYCEMIA. WE ARE UNABLE TO CONFIRM THE BENT CANNULA OR TO DETERMINE IF IT COULD HAVE CONTRIBUTED TO THE REPORTED HYPERGLYCEMIA. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. LOCKED DOWN SMARTPHONE: LOCKDOWN, OMNIPOD SOFTWARE APP VERSION: 3.1.2-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 THAT THE PATIENT WAS HOSPITALISED ON (B)(6) 2026 WITH HYPERGLYCAEMIA AND ELEVATED KETONES. WHEN THE POD WAS REMOVED FROM THE INFUSION SITE (ARM), THE CANNULA WAS FOUND TO BE BENT AND THE PATIENT¿S CAREGIVER REPORTED THEY WERE UNSURE IF THE CANNULA HAS BEEN PROPERLY INSERTED. THE PATIENT¿S BLOOD GLUCOSE LEVELS ROSE TO 35 MMOL/L (630 MG/DL) WHILE WEARING THE POD. IT WAS REPORTED THAT THE PATIENT EXPERIENCED VOMITING. IT WAS ALSO REPORTED THAT THE PATIENT HAD ¿ELEVATED HDK LEVELS¿. THE PATIENT WAS TREATED WITH MULTIPLE BAGS OF FLUIDS AND AN INTRAVENOUS INSULIN DRIP. THE PATIENT WAS DISCHARGED 15.5 HOURS LATER, ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715277 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Male Hospitalization