BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OMNIPOD 5 CONTROLLER

    MDR report key: 20535274 · Received October 25, 2024

    Report

    Report Number
    3004464228-2024-43582
    Event Type
    Injury
    Date Received
    October 25, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 25, 2024
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000022
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS IN THE HOSPITAL FOR AN UNKNOWN REASON. THE PATIENT'S BLOOD GLUCOSE LEVELS, SYMPTOMS, TREATMENT AND LENGTH OF STAY WERE NOT PROVIDED. IT WAS ALSO REPORTED THAT THE CONTROLLER APP WAS CRASHING, AND THE BLUETOOTH WOULD SAY IT WAS OFF, BUT THE PATIENT STATED THAT IT WAS ON. WE WERE UNABLE TO FOLLOW UP FOR ADDITIONAL INFORMATION DUE TO THE PATIENT NOT PROVIDING PHI/HIPAA CONTACT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1679838 OMNIPOD 5 CONTROLLER ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000409 10385083000022

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization