BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21323400 · Received February 6, 2025

    Report

    Report Number
    3004464228-2025-05338
    Event Type
    Injury
    Date Received
    February 6, 2025
    Date of Event
    January 4, 2025
    Report Date
    February 6, 2025
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    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 DIABETIC KETOACIDOSIS. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. CLOUD - LOCKED DOWN/SMARTPHONE LOCKDOWN. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION 3.1.1. CLOUD - SMARTPHONE OPERATING SYSTEM N5004L-AM-Q-MV01602-06-01.06. CLOUD - SMARTPHONE HARDWARE N5004L. CLOUD - CGM SENSOR TYPE G7. *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

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED WITH DIABETIC KETOACIDOSIS (DKA). THE PATIENT'S BLOOD GLUCOSE LEVELS REACHED 1,200 MG/DL WHILE WEARING THE POD. SYMPTOMS REPORTED INCLUDE HYPERGLYCEMIA AND LOSS OF CONSCIOUSNESS. THE PATIENT REPORTS THEIR HANDS AND FEET WERE PURPLE. THE PATIENT WAS TAKEN BY AMBULANCE TO THE HOSPITAL. THE PATIENT REPORTS THEY HAD AWAKEN IN THE INTENSIVE CARE UNIT AND WAS INTUBATED. THE PATIENT HAD X-RAYS ADMINISTERED OF THEIR LUNGS. THE PATIENT WAS DIAGNOSED WITH PNEUMONIA AS WELL AS DKA. THE PATIENTS POD WAS REMOVED. THE PATIENT WAS TREATED WITH INSULIN. THE PATIENT WAS GIVEN MEDICATION TO SLEEP AND FOR THEIR KIDNEYS AND LUNGS DUE TO PNEUMONIA. IN ADDITION, THE PATIENT REPORTS HAVING 2 BLOOD CLOTS. THE PATIENT REMAINS ON THE HOSPITAL FOR ALMOST A WEEK. THE PATIENT REPORTS THEY WILL BE GOING TO 10 DAYS OF THERAPY ONCE DISCHARGED FROM THE HOSPITAL INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918006 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Hospitalization