BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 20608544 · Received November 5, 2024

    Report

    Report Number
    3004464228-2024-44882
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 25, 2024
    Report Date
    November 5, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    20385083000432
    PMA / PMN Number
    K231826
    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/HYPOGLYCEMIA. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED AT PRINCE CHARLES HOSPITAL IN MERTHYR TYDFIL WITH HYPERGLYCEMIA. THE PATIENT'S BLOOD GLUCOSE LEVELS ROSE TO 29.5 MMOL/L (531 MG/DL) WHILE WEARING THE POD FOR BETWEEN 5 AND 24 HOURS. THE DOCTOR REMOVED THE POD FROM THE INFUSION SITE (LEG) ON (B)(6) 2024. WITHIN ONE HOUR, THE PATIENT WENT INTO HYPOGLYCEMIA AND THE BG LEVELS DROPPED AS LOW AS 3.6 MMOL/L (64.8 MG/DL). THE MEDICAL TEAM STATED THIS MAY HAVE BEEN DUE TO THE PATIENT'S HORMONES AND PROVIDED THE PATIENT WITH FLUIDS. THE PATIENT'S MOTHER STATED THEY ENDED UP CHANGING 6 PODS DURING THE HOSPITALIZATION. THE PATIENT WAS DISCHARGED ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120598 OMNIPOD 5 POD AUTOMATED INSULIN DELIVERY SYSTEM QFG INSULET CORPORATION PT-001443 PH1K01312431 20385083000432

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Female Hospitalization