BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 POD

    MDR report key: 21365984 · Received February 12, 2025

    Report

    Report Number
    3004464228-2025-06338
    Event Type
    Injury
    Date Received
    February 12, 2025
    Date of Event
    January 15, 2025
    Report Date
    February 12, 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. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED. *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. CLOUD - LOCKED DOWN/SMARTPHONE: NONE. CLOUD - OMNIPOD 5 SOFTWARE APP VERSION: NONE. CLOUD - SMARTPHONE OPERATING SYSTEM: NONE. CLOUD - SMARTPHONE HARDWARE: NONE. CLOUD - CGM SENSOR TYPE: NONE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED IN THE ICU (INTENSIVE CARE UNIT) DUE TO THE PRODUCT. THE PATIENT MENTIONED THAT THE POD'S FAIL BUT NO INFORMATION WAS PROVIDED. NO INFORMATION WAS PROVIDED ABOUT SYMPTOMS, HOW THEY WERE TREATED FOR THE ISSUE AND THE DURATION OF THE MEDICAL EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042528 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization