BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OMNIPOD 5 POD

    MDR report key: 15393796 · Received September 9, 2022

    Report

    Report Number
    3004464228-2022-16439
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 21, 2022
    Report Date
    August 24, 2022
    Manufacturer
    INSULET CORPORATION
    Product Code
    QFG
    UDI-DI
    10385083000114
    PMA / PMN Number
    K203768
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE COMPLAINANT THE DEVICE WILL NOT BE RETURNED FOR INVESTIGATION. WE ARE UNABLE TO CONFIRM THE REPORTED NEEDLE MECHANISM FAILURE OR DETERMINE ITS ROOT CAUSE. NO LOT RELEASE RECORDS WERE REVIEWED, AS THE PRODUCT LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    CORRECTION TO D1 - BRAND NAME CHANGED FROM UNAVAILABLE TO OMNIPOD 5 POD. D2A - COMMON DEVICE NAME CHANGED FROM UNAVAILABLE TO ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP. D2B - PROCODE CHANGED FROM UNAVAILABLE TO QFG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PINK SLIDE DID NOT MOVE FORWARD WHEN THE POD WAS ACTIVATED; THIS INDICATES THAT A NEEDLE MECHANISM FAILURE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307629 OMNIPOD 5 POD ALTERNATE CONTROLLER ENABLED INSULIN INFUSION PUMP QFG INSULET CORPORATION PT-000435 10385083000114

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown