BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM

    MDR report key: 22165571 · Received June 9, 2025

    Report

    Report Number
    3004464228-2025-24991
    Event Type
    Injury
    Date Received
    June 9, 2025
    Date of Event
    May 7, 2025
    Report Date
    June 9, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000138
    PMA / PMN Number
    K203768
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    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. LOT RELEASE RECORDS WERE REVIEWED, AND THE PRODUCT LOT MET ALL ACCEPTANCE CRITERIA. SPECIFICALLY, A POD IS PAIRED TO A PDM AND PUT THROUGH SIMULATED USE TESTING INCLUDING COMMUNICATING WITH THE PDM, DEPLOYMENT, DELIVERING FLUID, OCCLUSION DETECTION, AND FREEDOM FROM HAZARD ALARMS. CLOUD - LOCKED DOWN/SMARTPHONE DATA NOT AVAILABLE CLOUD - OMNIPOD 5 SOFTWARE APP VERSION DATA NOT AVAILABLE CLOUD - SMARTPHONE OPERATING SYSTEM DATA NOT AVAILABLE CLOUD - SMARTPHONE HARDWARE DATA NOT AVAILABLE CLOUD - CGM SENSOR TYPE DATA NOT AVAILABLE *PLEASE NOTE, THAT SECTION D IS CAPTURING THE DEVICE IDENTIFIERS AS REPORTED BY THE COMPLAINANT. THIS MAY NOT ALIGN TO THE DEVICE CONFIGURATION REPORTED IN H11, AS THIS DATA IS PULLED FROM OUR CLOUD BASED ON THE REPORTED DATE OF EVENT.

    Description of Event or Problem · 0

    AN MHRA USER REPORT HAS BEEN RECEIVED, REPORTED BY A HCP "THE 8 YEAR OLD GIRL WAS ON THE OMNIPOD5 PUMP. SHE HAD HER ROUTINE 3 DAY CHANGE ON THE EVENING OF (B)(6). FOLLOWING THIS SHE HAD SOME FOOD AND INSULIN FROM THEN ONWARDS SHE STARTED TO RUN HIGH. MUM GAVE CORRECTION DOSES OF INSULIN AT 22:39 AND 23:09. SHE WAS UNAWARE THAT BETWEEN THEN THE PUMP HAD AUTOMATICALLY TURNED ONTO MANUAL MODE. OVERNIGHT THE PUMP NEVER ALARMED TO NOTIFY THAT HER GLUCOSE LEVEL WAS HIGH. BY THE MORNING MUM REALISED THAT SHE WAS STILL RUNNING HIGH AND PUT HER BACK INTO AUTOMATIC MODE AND GAVE A 2 UNIT CORRECTION 05:26. THIS DIDN¿T DROP HER GLUCOSE LEVELS BY MUCH SO AT 06:57 MUM CHANGED THE POD AND A SMALL AMOUNT OF INSULIN WAS GIVEN. SLOWLY THE CHILD¿S GLUCOSE LEVELS DROPPED BUT HER KETONES WERE RISING LEADING TO HER STARTING TO VOMIT AND REQUIRED HOSPITAL ADMISSION FOR STABILISATION OF HER GLUCOSE AND KETONE LEVELS. ON ADMISSION TO [REDACTED] HER INITIAL BLOODS SHOWED THAT SHE WASN¿T IN DIABETIC KETOACIDOSIS. INFO TAKEN FROM HER CLINICAL RECORD BELOW ON HER MANAGEMENT. SEEN JUST AFTER 10:00 INITIALLY AND GIVEN A 0.3 UNIT BOLUS OF INSULIN TO TRY AND SWITCH OFF HER KETONES AND BRING DOWN HER BG A LITTLE MORE. TARGET BG DROPPED TO 6.1MMOL/L ADVISED TO TRY APPLE JUICE 5MLS EVERY 5-10 MINUTES) 10:00 BG- 16.8MMOL/L, BK- 3.6MMOL/L. 12:00 BG- 8.0MMOL/L, BK- 3.3MMOL/L. BOLUS OF 0.25 UNITS OF NOVORAPID GIVEN VIA POD, CONTINUE APPLE JUICE. 14:00 BG- 6.8MMOL/L, BK- 2.2MMOL/L. BOLUS OF 0.15 UNITS GIVEN WITH 50MLS OF APPLE JUICE. DISCHARGED AFTER 17:00 ONCE BLOOD KETONES WERE BACK BELOW 1.0MMOL/L".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476860 OMNIPOD 5 AUTOMATED INSULIN DELIVERY SYSTEM ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000438 H000587 10385083000138

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Female Hospitalization